cyrilzakka/clinical-trials huggingface dataset:
DiagNostic Study of Low-dose CT and multipleX PCR on Antibiotic Treatment and Outcome of Community-Acquired Pneumonia

Rationale:

Uncertainty in the clinical and etiological diagnosis of community-acquired pneumonia (CAP) often leads to incorrect treatment and unnecessary use of broad-spectrum antibiotics. Establishing the clinical diagnosis of CAP is hampered by the suboptimal sensitivity of chest radiograph to detect pulmonary infiltrates (\~70%). Establishing the etiological diagnosis is also hampered, mainly because of the inevitable diagnostic delays and low sensitivity of routine microbiological tests. There are currently no recommendations for low-dose chest computed tomography (low-dose CT) or viral and bacterial point-of-care multiplex polymerase chain reaction (PoC-PCR) in the diagnostic work-up of CAP patients, because the data supporting such an approach are lacking.

Objective: The aim of this study is to determine the added value of low-dose CT and PoC-PCR in the diagnostic workup of patients with CAP hospitalised to non-intensive care unit (ICU) wards in minimizing selective antibiotic pressure while maintaining patient safety.

Study design: Cluster-randomised controlled trial with historical control period.

Study population: Adult patients (\>=18 years old) with a clinical diagnosis of CAP requiring hospitalisation to a non-ICU ward.

Intervention: Intervention arm 1: availability of PoC-PCR during the ER visit; intervention arm 2: performing low-dose CT from the ER or at least within 24 hours; control arm: standard care.

Main study parameters/endpoints: The primary effectiveness outcome is days of therapy of broad-spectrum antibiotics. The primary safety outcome, on which the sample size is calculated, is 90-day all-cause mortality.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with performing the PoC-PCR and the radiation of the low-dose CT is of negligible risk. Nasopharyngeal swab collection causes a temporary unpleasant sensation. The low-dose CT can reveal unexpected findings which may require additional diagnostic procedures, for which the treating physician will use state-of-the-art guidelines. Treatment recommendations to de-escalate or stop antibiotic treatment may be beneficial for the individual patient by minimising exposure to antibiotics and improve targeted use of antibiotics. Final decisions are always made by the treating physician taking into account all clinical information.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or above;
* working diagnosis of CAP at the emergency department with the presence of at least two clinical criteria or one clinical criterion and radiological evidence of CAP, with no other explanation for the signs and symptoms;
* requiring hospitalisation to a non-ICU ward via the ER.

Exclusion Criteria:

* Hospitalisation for two or more days in the last 14 days;
* Residence in a long-term care facility in the last 14 days;
* History of cystic fibrosis;
* Severe immunodeficiency
Externalization and Stimulation

The distinction between self-generated and external information is impaired in patients with schizophrenia, who are assumed to confuse imagination with real perceptions. To better understand the underlying mechanisms of these abnormalities, the investigator will investigate the brain mechanisms supporting auditory externalization. Auditory externalization is the ability to perceive whether a sound comes from inside or outside oneself. Our study, in healthy participants, will use functional brain imaging to identify the brain areas involved in the externalization of sound sources and to test whether neuromodulation of this area can modify this ability and provide a therapeutic lead in pathological populations

30 healthy participants will be included. The participants will undergo three separate visits. During the first one, the participants will listen to sounds coming from either internal or external sources while undergoing an fMRI session. This will allow us to identify the brain region involved in externalizing abilities with the highest activity. In the second and third visits, this specific region will be targeted by HD-tDCS (a non-invasive high-definition neuromodulation technique whose precision is enhanced by individual data) to modulate its activity and test its causal involvement in externalization processes. Each participant will receive both active and placebo stimulation, with the order counterbalanced. During the stimulation, participants will complete an externalization task, followed by a reality monitoring task and a self-agency task. Additionally, the investigator will gather socio-demographic and psychometric data.

Eligibility Criteria:
Inclusion Criteria:

* Having given their written informed consent
* Affiliated with a social security scheme
* French speakers and readers

Exclusion Criteria:

* With contraindication to HD-tDCS stimulation or fMRI
* With a history of or current hearing problems, including tinnitus
* Taking medication (except contraceptives)
* With a history of or current psychiatric diagnosis (DSM-5 criteria)
* First-degree relatives with a diagnosis of schizophrenia spectrum disorder or bipolar disorder (DSM5)
* Have a personal history of neurological disorders or head trauma with loss of consciousness
* With an intellectual disability (Raven's Matrices)
* With developed musical abilities (i.e., regular practice of a musical instrument for at least 10 years with assiduity or at a music school or conservatory)
* Pregnant or nursing
* Being in a period of exclusion and/or having exceeded the annual indemnity ceiling (€4,500) for other clinical research.
* Under guardianship
Food Supplement Physiomanna® Baby in Pediatric Patients

The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation

The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.

This is an interventional, non-controlled, multicenter trial with a prospective design in one cohort of patients. This clinical investigation will be performed in 3 centers in Romania.

The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM to be more than 2 times per week.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients between the ages of 0 to 8 years;
* Functional constipation according to ROME III criteria (Annex 2);
* Two or fewer SBM during the previous week; SBM is defined as BM not preceded after a 24 h administration with a laxative or enema;
* To be otherwise in good health, as judged by a physical examination;
* Mentally competent parent or tutor to sign an informed consent

Exclusion Criteria:

* Known history of organic cause for the constipation;
* Congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases);
* Fecal Occult Blood Test (FOBT) positive in the 4 previous weeks;
* Fecal impaction at baseline, or during the trial period, as indicated by the physical examination;
* Known or suspected perforation or obstruction other than fecal impaction;
* History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy;
* Use of concomitant medications that cause constipation in the previous 3 months;
* Concomitant use of herbs and other dietary supplements, such as: stimulant laxative herbs and/or potassium depleting herbs;
* Concomitant use of cardiac glycosides(e.g. Digoxin);
* Patients who, according to the investigator, should not be included in the study for any reason, including the parent's inability to follow the study procedures;
* Patients with known allergy to Fraxinus Manna, mannitole, fennel, lemon balm or chamomile;
* Patients with clinically significant elevations of TSH or abnormal plasma electrolytes in the 4 previous weeks;
* Patients who, within the past 30 days have participated in an investigational clinical study;
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Willing and able to provide written informed consent
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm)
* All imaging evidence used as part of the screening process must be within 28 days
* Suitable for either treatment regimen
* WHO performance status 0-1
* Adequate hematological, renal and hepatic function
* Life expectancy of at least 3 months without any active treatment

Exclusion Criteria:

* Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
* Previous radiotherapy delivered to the liver
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
* Peripheral neuropathy \> grade 2 (NCI-CTC)
* Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
* Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
* Pregnant or breast feeding
* Concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
* Allergy to contrast media that would preclude angiography of the hepatic arteries
An Algorithm Creation by Automated Segmentation by MRI for Bone and Muscles of Shoulder

The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.

This is a national monocentric study which will be conducted in Ambroise Paré hospital of APHP, in orthopaedics department (for enrollment) and radiological department (for CT-scan and MRI examinations) respectively.

Manual segmentations of 5 muscles and 2 bones of shoulder by MRI with automated segmentation of shoulders corresponding to CT-scan imagings.

3D imagings of each shoulder by manual segmentations from MRI and automated segmentation from computed tomography will provide to build a network.

The perspective of the elaborated algorithm should lead to an automated 3D-reconstruction of patients' shoulder as a routine care in surgery.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer \> 18 years, presenting any symptom nor history of shoulder pathology;
* Affiliated to social security scheme.

Exclusion Criteria:

* Symptoms or history of shoulder pathologies;
* Claustrophobia;
* Pregnant woman;
* Patient covered by AME system;
* Contre-indication to perform MRI examination (implant, less 6-months stent implantation, recent surgery, renal insufficiency, pace maker implantation, cardiac defibrillator, cardiovascular catheter, neurostimulation, implantable electronic pompe for automatic injection of medications).
Biochemical and Genetic Markers in Liver Diseases

Investigation of biochemical and genetic markers in liver disease that might have an influence on the course of the disease


Eligibility Criteria:
Inclusion Criteria:

* suffering from liver disease
* age of 18 years or older
* agreement to participate in study

Exclusion Criteria:

* younger than 18 years
* no consent to participate
Gustatory Modulators Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy

Identify possible modulators for developing gustatory dysfunction among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using a questionnaire ( appendix) with a binary measuring unit (yes/no).

PECO

* P Population: depressed Egyptian adults under anti-depressants therapy
* E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL)
* E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)
* C control (non exposure) : non-pharmacological treatment ( psychotherapy)
* O Outcome: Identify possible gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Eligibility Criteria:
Inclusion Criteria:

* • Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy)

  * Age from 20 to 50 years old

Exclusion Criteria:

* Antipsychotics

  * Hypnotics
  * Anticonvulsants
  * Ages other than the mentioned • Olfactory dysfunction
  * Chemosensory dysfunction
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach

Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli during various stages of surgery. None of routinely used anesthetic agents effectively blunts the undesirable hemodynamic responses, and therefore usually there is a need to use increased doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because its sympatholytic and antinociceptive properties may ensure optimal intraoperative hemodynamic stability during critical moments of surgical manipulation. In addition, DEX reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic requirements

DEX as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing TNTS resection of pituitary tumor. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia

Eligibility Criteria:
Inclusion Criteria:

1. Age18-65
2. ASA 1-2
3. Elective TNTS resection of Pituitary Tumor
4. No narcotic before surgery as premedication
5. Able to Extubate

Exclusion Criteria:

1. GCS less than 15
2. Preoperative Heart Rate less than 50 beat/min
3. No Beta-Blockers
4. Pregnant patients
5. Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist
6. Hemodynamic unstable
7. Systolic BP more than 160mmHg
8. CAD
9. Renal insuffuciency
10. Allergy in dexmedethomidine and opioid
11. BMI more than 30
12. Denied consent
Vascular Endothelial Factor Gene Polymorphism in Preeclampsia

In this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with Doppler changes in the pulsatility index of the umbilical artery.

Preeclampsia is a syndrome characterized by occurrence of hypertension and proteinuria after 20 weeks of gestation. The pathophysiology of preeclampsia involves abnormalities in the development of placental vasculature early in pregnancy may result in relative placental under perfusion/hypoxia/ischemia, which then leads to release of factors into the maternal circulation that alter maternal endothelial function and cause hypertension and other manifestations of disease .Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. Human VEGF gene is located on chromosome 6 and consists of 8 exons with alternate splicing, forming a family of proteins. There are several common single nucleotide polymorphisms (SNPs) in the VEGF gene, which could alter gene expression and protein production, and alter the risk of developing diseases characterized by deranged angiogenesis including preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

More than 20 weeks gestation. Preeclamptic patients

Exclusion Criteria:

association with chronic disease (cardiac, hepatic, renal) and if the patient was known to have chronic hypertension.

association with auto-immune disease.
A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer

The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.


Eligibility Criteria:
Inclusion Criteria: - Histologically confirmed breast cancer Stage I, II or III - Candidate for IV CMF chemotherapy (every 4 weeks) for a total of 6 cycles - Chemotherapy naïve (prior treatment with hormone therapy or with anti-HER2 monoclonal antibody therapy is permitted as long as treatment has been stopped prior to enrollment into the study) - Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L - Platelet count greater than or equal to 100 x 10\^9/L - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Written informed consent before any study specific procedure Exclusion Criteria: - AST and/or ALT greater than 1.5 x upper limit of normal (ULN) concomitant with alkaline phosphatase greater than 2.5 x ULN according to institutional standard - Bilirubin greater than 2 x ULN according to institutional standard - Inadequate renal function (creatinine greater than 1.5 x ULN according to institutional standard) - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemias) - History of prior malignancy other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy - Prior radiotherapy - Scheduled concomitant radiotherapy (e.g., radiotherapy administration while on study) - Documented active infection at the time of enrolment requiring use of systemic anti- infectives - Documented positive test for human immunodeficiency virus (HIV) infection - Known hypersensitivity to E coli derived products \[e.g., Filgrastim (Neupogen®), pegfilgrastim (Neulasta®), HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®\] - Subject is currently enrolled in or 30 days have not passed since completing other investigational device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented) - Pregnant or breast-feeding (for subjects of child bearing potential) - Not using adequate contraception (for subjects of child bearing potential) - Previous participation in this study - Inability or unwillingness to comply with the protocol procedures
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.


Eligibility Criteria:
Inclusion criteria:

* Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
* Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:

  * PASI score of 10 or greater and
  * IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)

Exclusion Criteria:

* Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
* Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L \[2.0 mg/dL\]) and hypertension at screening.

Other protocol-defined inclusion/exclusion criteria may apply
Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity

The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 60 years old;
* Skin types: I (light caucasian) or III (light brown);
* Intact skin where the product will be applied;
* Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Use of photosensitizing drugs;
* History or photodermatoses activities;
* Personal or family history of photoinduced skin cancer;
* Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
* Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;

  * Previous participation in a study with the same product under test;
  * Relevant medical history or current evidence of alcohol or other drugs abuse;
  * Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
  * Sponsor's employees involved in the study, or close family member of an employee involved in the study;