cyrilzakka/clinical-trials huggingface dataset:
Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures

The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).

Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.

Randomized, open and prospective clinical trial.

Following the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments:

Control group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.

Experimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.

Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.

After the surgery, patients will be followed-up at 6 weeks, 3 and 6 months. At those times, data related to the radiological examination, the appearance of complications and the walking ability evaluation scale (FAC) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment.
* Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.

Exclusion Criteria:

* Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture.
* Subcapital fracture of the proximal femur.
* Subtrochanteric fracture of the proximal femur.
* Pathological fracture.
FAME II-10-year Follow-Up

The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design.

The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence.

FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published.

The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).

Patients will have to sign a specific informed consent for the present 10-year follow-up.

This study will be conducted for about approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with

   1. stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3)
   2. or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
   3. atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
2. In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
3. Eligible for PCI
4. Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG
2. Patients with left main coronary artery disease requiring revascularization
3. Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
4. Prior CABG
5. Contra-indication to dual antiplatelet therapy
6. LVEF \< 30%
7. Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
8. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
10. A life expectancy of less than 2 years
11. Age under 21
12. Pregnancy or intention to become pregnant during the course of the trial
13. Refusal or inability to sign an informed consent. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
14. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
15. Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed
Evaluating the Neurobiological Basis of Traumatic Dissociation in Women with Histories of Abuse and Neglect

This study aims to evaluate the neurobiological basis of traumatic dissociation in a cross-diagnostic sample of women who have histories of childhood abuse and neglect.

Dissociative symptoms commonly are associated with exposure to traumatic stress. Preliminary evidence from functional magnetic resonance imaging-based analysis (fMRI) of neural activation during dissociative symptom provocation in patients with PTSD or DID has implicated certain key structures involved in the generation of dissociative symptoms. Given the presumed region-to-region neural interplay implicit within this model, the investigators believe the use of intrinsic functional connectivity MRI (fcMRI) represents a valuable next line of investigation into the neurobiology of traumatic dissociation. The investigators also believe that a genetic approach holds promise as another converging line of inquiry into our understanding of traumatic dissociation.

To evaluate the neurobiological basis of traumatic dissociation, this study will recruit patients with PTSD or DID, and recruit matched controls to identify neurobiological correlates of traumatic dissociation.The study will compare the phenomenology of traumatic dissociation in patients with different PTSD subtypes and DID using standardized measures to look at the neurological and genetic correlates.

This study will also include a follow up visit that includes neuroimaging and genetic assessments.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Clinical diagnosis of PTSD or DID and history of childhood abuse, or healthy controls
* Age between 18 and 89
* Legal and mental competency of the patient

Exclusion Criteria:

* Male
* Under 18 or over 89
* Legal or mental incompetence
* Delirium secondary to medical illness
* PTSD or DID due to general medical or neurological illness
* History of neurological conditions that may cause significant psychiatric symptomatology (e.g., dementia)
* Any contraindication to MR scans, including claustrophobia, pregnancy, metal implants, etc.
* Current alcohol or substance dependence or abuse (within the last month)
* A history of schizophrenia or other psychotic disorder
* History of head injury or loss of consciousness for longer than 5 min (including concussion)
Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.


Eligibility Criteria:
Inclusion Criteria:

* Completed month 36 of Study RVN-008993.
* Underwent an iliac crest bone biopsy at month 36.

Exclusion Criteria:

* Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.
0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

This study will determine the safety and efficacy of diluted bleach bath solution as final rinse on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis..

Objective: To determine the safety and efficacy of 0.005% sodium hypochlorite final rinse solution on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis.

Design: Randomized, double blind, controlled clinical trial. Setting: Makati Medical Center, Dermatology Outpatient Department Participants: Patients with mild to moderate atopic dermatitis, seen at Makati Medical Center Dermatology Outpatient Department.

Sample size: 68 (34 treatment group, 34 placebo group) Intervention: Eligible patients will be randomly allocated to two groups. The subjects will either be in the treatment group (0.005% sodium hypochlorite) or in the placebo group (bath water). Subjects will use a liter of 0.005% sodium hypochlorite as a final rinse solution during bathing for the treatment group and a liter of bath water for the placebo group. This intervention will be done twice a week for 12 weeks. Both patients and assessors will be blinded to the treatment assignments.

Assessment of Outcome: The outcomes will be assessed at weeks 4 and 12. Primary outcome measure will use culture findings, physician's global assessment (PGA) of severity of disease and eczema area and severity index (EASI) score. Secondary outcome measure will assess adverse effects during follow-up at weeks 4 and 12.

Data Analysis: Kruskal-Wallis Test will be used to compare the significant difference in scores between the two groups and Wilcoxon Signed Rank Test will be used to compare significant difference of before and after scores within each group.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females more than 8 years old.
2. Subjects with clinical diagnosis of atopic dermatitis (based on Hannifin and Rajka criteria).
3. Healthy subjects with no other skin disease.
4. Subjects without any prior topical or oral antibiotic two weeks prior to the enrollment period. Those who had undergone course of topical and oral antibiotic are given at least 2 weeks washout period.

Exclusion Criteria:

1. Severe Atopic dermatitis requiring hospitalization.
2. Hospitalized and debilitated patients.
3. Subjects with other serious skin disorder, pigmentation or extensive scarring in affected areas.
4. Subjects who have a known history or clinically relevant allergy, in particular to chlorine containing compounds.
5. Pregnant women and nursing mothers.
6. Subjects who are in a situation, which, in the opinion of the investigator, may interfere with optimal participation in the study.
7. Subjects participating or having participated in a clinical trial within 1 month before enrollment in the study.
8. Subjects who cannot communicate with the investigator (\>18 years old) or are unaccompanied by parent or legal guardian (\<18 years old).
9. Subjects who are unable to follow-up.
EPR (Electron Paramagnetic Resonance) as Method of Non-invasive Characterization of Melanin Content in Skins With Different Phototypes

The aim of this study is to assess the signal of melanin using Electron Paramagnetic resonance (EPR). Melanin is a paramagnetic pigment detectable by EPR. Recent advances in instrumentation allows the application of EPR in human beings. The characterization of melanin by EPR could be potentially interesting in the context of melanoma detection and characterization. While another clinical study is currently ongoing aiming at demonstrating the feasibility of the non-invasive detection of the EPR signal of melanin in melanoma patients, it is crucial to have a control group with healthy skin. The aim of the present study is to assess the influence of skin pigmentation of the EPR signal recorded. In the present clinical study, the EPR signal of melanin will be characterized in healthy skin with different phototypes (1-2, 3-4, 5-6) to assess the potential influence of skin pigmentation on the EPR signal.

Electron paramagnetic resonance (EPR), also known as electron spin resonance (ESR), is a spectrometric method enabling the observation of the absorption of energy by the free radicals contained by a sample immerged in a strong homogenous magnetic field. An EPR spectrum reveals only the presence of paramagnetic centers and can thus only be observed with samples containing lone unpaired electrons. In water-containing biological environments, most of free radicals are very reactive and have a very short life. To detect such species, a strategy is to use extrinsic molecules that will react with these species to form EPR measurable adducts. This technique is called "spin trapping". In contrast, the study of stable free radicals does not require the use of spin-trap agents. Melanins are part of the rare stable biological radicals directly observable with EPR. In practice, melanin is the only endogenous stable radical that can be detected using 1 GHz EPR.

The aim of the present study is to measure the EPR signal recorded from skin with different pigmentations. 45 healthy volunteers will be enrolled:

15 subjects with phototype 1-2, 15 subjects with phototypes 3-4, 15 subjects with phototypes 5-6. The parameters described hereafter will be investigated:

* g factor (resonance condition); expected g=2.005;
* shape of the signal, presence of a shoulder at g=2.01 due to pheomelanin;
* intensity of the signal (signal height, double integration, double integration relative to reference).

This will provide a database for other ongoing studies carried out in patients with suspicious lesion (nevi vs melanoma)

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with skin belonging to Phototype I-II, III-IV, V-VI

Exclusion Criteria:

* Subjects under 18 years
* Subjects with pacemakers
* Subjects with non-removable implants with metal or otherwise not known to be MRI-compatible.
* Pregnant women
Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation

The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV.

One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients scheduled for lung resection surgery.

Exclusion Criteria:

* severe cardiovascular disease
* severe alteration of the preoperative pulmonary function, with FEV1 70-120% predicted and FEV1/FVC ≥ 70% predicted considered to be normal.
Analysis of Emergency Department Visits According to Incidence of Covid-19

With lockdown, Emergency Departments (ED) visits decrease, principally for visits unrelated with Covid-19. In this study, the investigators aimed to find a correlation between ED visits and incidence rate of Covid-19 in a French metropolis.

All patients older than 18 years were included in 9 ED during 51 weeks. Patients transferred between the centers participating in the study were excluded.

The investigators count the number of visits per weeks, then the number of visits according to :

* reason for consultation Covid-like (cough, fever or dyspnea),
* reason for consultation with accordance to French Emergency Medicine Society (SFMU) reference
* diagnosis with accordance to SFMU reference
* orientation (home, medical unit, chirurgical unit, intensive care unit, psychiatric unit, death)

Pearson's correlation test compare incidence rate per week with this counts and admission rate.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old

Exclusion Criteria:

* patient who are transferred between centers participating to the study.
A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery

This is a prospective, exploratory study to verify intra-operative handling and safety and to collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a small bioresorbable device for the immediate immobilization of the facet joint.

Patients eligible for study enrollment will present with degenerative lumbar spinal diseases involving the L4/L5 segment and requiring spinal fusion.

The Turris® Facet Fuser is an investigational resorbable device intended to support spinal segment fusion in individuals suffering from degenerative lumbar spinal diseases. The device is directly inserted in the facet joint of the affected segment using the BoneWelding® technology, a soft tissue sparing, ultrasound based insertion method which confers immediate stability to the implant.

Aim of this prospective, exploratory study is to verify intra-operative handling and safety of the Turris® Facet Fusion System and to collect preliminary short-term safety and efficacy data on this innovative implant by observing the healing process over a period of one year.

Eligibility Criteria:
Inclusion Criteria:

* one-level fusion at L4/L5 with dorsal instrumentation and, if required, with monolateral decompression and/or intervertebral disc removal and implantation of an intervertebral implant

Exclusion Criteria:

Patient

* had previous surgical stabilizations at the involved or adjacent levels
* has lytic spondylolisthesis
* has degenerative spondylolisthesis grade II or higher
* has radiographic signs of significant instability and/or hypermobility of the segment (\>3mm translation, \>11° rotation difference from adjacent level)
* has scoliosis \> 10° at the involved segment
* has osteoporosis to a degree that spinal instrumentation would be contraindicated.
* has presence of active malignancy.
* has overt or active infection, either local or systemic
* is less than 18 years old
* is pregnant or plan a pregnancy during the study duration
* has a BMI \> 35
* has a progressive neuromuscular disease
* has a condition which requires postoperative medications that may interfere with bone metabolism
* has a history of autoimmune disease
* has a history of endocrine or metabolic disorders known to affect osteogenesis
* is mentally ill or incompetent
* is an alcohol and/or drug abuser
* is not available for follow up visits
Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery

This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response

Inflammation is a central component of the immune response. In its acute form it aids the transition from disease to health via the activation of numerous immune cells, enabling them to reach the site of infection/injury and orchestrate themselves to combat pathogens, facilitating resolution and repair to restore the host to health. However, chronic inflammation is deleterious to the host and differs from the "classical" acute inflammatory process in that the inflammation is not necessarily so readily obvious and is not self-limiting; rather, the immune system is in a constant state of low-grade activation and when challenged by pathogenic or sterile injury the response is heightened, resulting in prolonged tissue damage and a failure of efficient resolution mechanisms.

Neutrophils are important mediators of acquired innate immune responses but may also contribute to the pathogenesis of chronic inflammatory diseases. Neutrophils are heavily involved in antimicrobial defence; their primary role is the localisation and elimination of pathogenic microorganisms. This, combined with their relatively short lifespan, has resulted in a traditional view of them as limited "kamikaze" cells. However, as detailed here, neutrophils have been shown to act with complexity and sophistication, orchestrating the immune/inflammatory response but also inadvertently contributing to tissue damage in different disease states. This study investigates the chronic long-term health condition of obesity and its effect on neutrophil function and the inflammatory response

Eligibility Criteria:
Inclusion Criteria for Bariatric participants:

* BMI \>40
* Undergoing Gastric Band surgery

Exclusion Bariatric Participants Criteria:

* Undergoing alternative weight loss surgery
* BMI\<40
* Smoking
* Pregnancy

Exclusion criteria for the controls

* BMI over 27
* pregnancy
* smoking
* evidence of systemic disease
* use of medications/vitamin supplements.