cyrilzakka/clinical-trials huggingface dataset:
Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel

The main goal of the surgical correction of the hallux valgus is the morphological correction associated with the functional rebalancing of the first ray. The aim of this study was to show the efficacy of piezosurgery in performing distal linear osteotomy of the first metatarsal bone in hallux valgus correction, in terms of clinical and radiological outcomes at 1-year final follow up.

This study was performed collecting pre-operative and post-operative data for all patients.

At the time of admission, the patients received and signed an Informed Consent to adhere to the Study Protocol. On this occasion, the patients were also given a summary scheme of the clinical and radiographic checks to which they would have undergone in case of adherence to the Study Protocol.

40 patients were included in the trial and were randomly allocated (1:1) in a Piezoelectric Group (PG) and in a Control Group (CG) (that provided for the use of a traditional oscillating saw) utilizing sealed envelopes. The envelopes were prepared and shuffled by the same senior surgeon involved in the surgical procedures and drawn by a researcher not involved in the surgical procedures or the clinical and radiographic assessment.

The patients were not aware of the instrument used during surgery. In both groups, patients were treated with the same surgical technique, a distal linear osteotomy of the first metatarsal bone (S.E.R.I. technique). Clinical and radiographic assessments were performed during the multiple follow-ups.

The final follow-up was at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Mild to moderate hallux valgus (Hallux valgus Angle \<; 40° and Intermetatarsal Angle \< 20°),
* No osteoarthritis or grade 1 osteoarthritis of the first metatarsophalangeal joint (MTPj) according to Regnauld grading

Exclusion Criteria:

* Stiffness of the first MTPj or osteoarthritis ≥ grade 2 according to Regnauld's classification
* Rheumatoid arthritis or other chronic inflammatory joint diseases
* Diabetes
* Neurological disorders
* Previous hallux valgus surgical corrections
* Hypermobility of the first MTPj as per congenital laxity syndromes.
Alcohol Cessation Intervention in an Acute Surgical Setting

Hazardous alcohol intake is an independent risk factor for postoperative complications after major and minor operations, elective and emergency procedures for men and women.

The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for alcohol cessation intervention in the perioperative period compared to the daily routine guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* Drinking 21 or more drinks(one drink containing 12 g ethanol) per week for at least 3 months
* Traumatic ankle fracture requiring internal fixation (osteosynthesis; more than just Kirschner threads or similar minor intervention)
* Informed consent
* Randomisation within 36 hours after entering the orthopaedic department

Exclusion Criteria:

* Major trauma involving other fractures or major lesions,
* Preoperative severe psychiatric disorders (including medicine addiction, severe alcohol dependence \[defined as experience of delirium or seizures during abstinence from alcohol\], dementia) or other conditions of reduced ability for giving informed consent
* Pathological fractures
* Pregnancy and lactation
* Allergy to benzodiazepines, anaesthesia, pain treatment or disulfiram
* Uncompensated chronic diseases (including fulminate cardiac or liver insufficiency, which are contraindications for disulfiram)
* ASA score 4-5
* Canceled operation
* Withdrawal of informed consent
Brain Glioma Registry Combining Clinical and Imaging Information

This registry aims to collect clinical and radiologic information including detailed clinical, conventional MR and advanced MR imaging data of patients with brain gliomas. Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and chemical exchange saturation transfer (CEST) imaging. This registry will describe course of disease and long-term outcomes of brain gliomas.

Though the cure for brain glioma- from low grade to glioblastoma- is yet to be found, seeking for curable treatment option is actively developing. Multimodal advanced MR imaging (contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging) on 3 Tesla have shown potential in patients with glioma to monitor treatment response with quantitative assessment. To find suitable imaging biomarker for treatment response, assessing clinical and radiologic outcome for long-term is essential. The creation of a registry for brain glioma in long-term follow up provides an overview of the clinical, relevant treatment standards, advanced MR imaging information, and survival data of patients and thus create opportunities for imaging biomarker research.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of Brain Glioma
* Life expectancy of greater than 3 months
* Must receive a first- or second-line therapy
* Signed informed consent

Exclusion Criteria:

* No brain gliomas
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
Phase I Safety Study of Anti-HIV Immune Serum Globulin (Human)

To investigate the potential benefit of providing passive immunity with hyperimmune anti-HIV human serum.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Proof of HIV infection.
* Diagnosis of asymptomatic HIV infection or early AIDS related complex (ARC) with no zidovudine (AZT) or other anti-HIV therapy. OR a diagnosis of AIDS and = or \> 3 months of AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* HIV-induced neurological disease.
* IgA negative.

Concurrent Medication:

Excluded:

* Immunomodulating agents.
* Steroids.
* Interferons.

Patients with the following are excluded:

* Active substance abuse.
* Use of immunomodulating drugs such as steroids or interferons.
* HIV-induced neurological disease.
* IgA negative.

Required with a diagnosis of AIDS:

* = or \> 3 months of zidovudine (AZT) therapy.

Active substance abuse.
The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker

A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly. Pacemakers are essential when dysrhythmias or conduction defects compromise the electrical system and the heart's hemodynamic response.

The current status aimed to assess the feasibility of motivational interviewing on emotional intelligence, dispositional optimism, and adherence to care practices among patients with permanent pacemaker.

According to the Miller and Rollnick principles, the framework of the motivational interviewing group's sessions was taken from the workbook of the intervention's six motivational interviewing sessions. A researcher recruited participants in groups of 7 patients for six sessions of 60-90 minutes each (two sessions per week). The training sessions covered stress alleviation, appropriate drug usage, quitting smoking, regular physical activity, healthy eating habits, and regular physical activity. Patients in the control group got standard treatment for PPM, including education on proper medication usage, nutrition, exercise, and regular checking.

Eligibility Criteria:
Inclusion Criteria:

* Patients with permanent cardiac pacemaker implantation aged from 20 up to 65 years old.
* Both sexes (male \& female).
* Able to communicate verbally.
* Free from psychotic disorders.
* Not scheduled for other surgeries.
* Agree to participate in the current study.

Exclusion Criteria:

* Patients with severe mental problems
Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.

The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.

Evaluation of the VQ11 auto-questionnaire of quality of life in pneumology investigation, during the implementation of a long-acting bronchodilator treatment of patients with COPD.

Two visits per patient are planned:

V1: After complete information and collection of the written consent, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.

V2 (3 months after the treatment setup, at day90 ± 15): the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales and Likert scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.

Inclusion period : 6 months; Study participation period / patient : 3 months; Complete study duration : 9 months

Eligibility Criteria:
Inclusion Criteria:

* COPD patient with stage II, III ou IV justifying a LABD
* Patient in stable state (without exacerbation in the previous 6 weeks)
* Clinical criteria: dyspnoea stage I ou more (MMRC scale)
* Adult over 18 years old.
* Patients naïve from LABD treatment.

Exclusion Criteria:

* Other associated pathology (bronchiectasia...)
* Heart disorder with a prevailing role in the dyspnoea
* Cardiac decompensation in the previous year
* Pregnancy and lactating
* Women in genital activity without efficient contraception method (IUD or estrogen-progestin pill)
* Lack of social insurance
* Patient non compliant to protocol, at the investigator's appreciation
* Simultaneous participation to other clinical trial.
* adult under judicial protection (tutor or curator).
Epidemiology of French Sexual Offenders. A Cross-sectional Study

The epidemiology of sexual offenders has been poorly studied in the literature. A retrospective and prospective study will allow for the examination of the clinical profile of sexual offense perpetrators, risk and recurrence factors, as well as psychiatric or medical treatment. Since 2015, the Auvergne-Rhône-Alpes region has 8 reference platforms for sexual offense perpetrators, offering personalized assessment according to criteria defined by the Regional Health Agency (ARS). After this assessment, a multidisciplinary meeting is organized to define a tailored care plan. This study, called ARAVS (Auvergne Rhone-Alpes Sexual Offenders), aims to conduct an epidemiological, clinical, and socio-demographic study of patients in these platforms.

The Auvergne-Rhône-Alpes region, prompted by the Regional Health Agency (ARS), established a unique system of reference platforms starting in 2015, covering a large part of the region\&#39;s territory. These platforms aim to provide comprehensive care for sexual offense perpetrators in addition to the support provided by the CRIAVS (Resource Centers for Professionals Working with Sexual Offenders). There are currently 8 active reference platforms in the region: in Bourg-en Bresse (Ain), Roanne (Loire), Saint-Etienne (Loire), Lyon (Rhône), Clermont-Ferrand (Puy-de-Dôme), Grenoble (Isère), Annecy (Savoie), and Valence (Drôme).

Given this context, it seems pertinent to implement a retrospective-prospective study of the clinical and epidemiological characteristics of patients treated in these reference platforms to better understand this population. These results will contribute to a better understanding of sexual offense perpetrators in France, as there is limited large-scale clinical data available, and will help tailor care tools to the population being treated in the region. Standardizing the use of common tools, which are currently being used heterogeneously, will also enrich the resources available to clinicians across all platforms by generalizing their use.

The coordinated organization of the reference platform network in the Auvergne-Rhône-Alpes region constitutes a unique care network in France, conducive to a clinical analysis of patients and their care pathways. The project will thus allow for the study of care pathways, the clinical and social profile of sexual offenders, and the identification of risk factors for recurrence among patients based on the data collected.

Eligibility Criteria:
All sexual offenders who are part of the PFR and meet the inclusion criteria will be invited to participate in this study.

Inclusion criteria:

* Adults (age ≥ 18 years).
* Under injunction of care for a sexual offense.
* Or Awaiting sentencing for a sexual offense.
* Or Currently under legal proceedings for a sexual offense.
* Or Under a legal obligation for care related to a sexual offense.
* Or Falling within the scope of an alternative to incarceration for a sexual offense.

Exclusion criteria:

* Patient refusal to participate in the study.
* Patients with physical or mental incapacity to complete the questionnaires.
Fondaparinux in Critically Ill Patients With Renal Failure

The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing venous thromboembolism (VTE). Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 hr, in patients with estimated creatinine clearance of \< 30 ml/min, will be safe and effective.

We will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure (AKI) with intermittent hemodialysis (IHD) and 3) Acute renal failure with continuous renal replacement therapy (CRRT). All patients will be assessed for efficacy of the dose. Efficacy will be assessed by following clinically for any evidence of VTE, either deep venous thrombosis (DVT) or pulmonary embolism. In addition, lower extremity duplex studies will be performed at baseline and at the end of the study period to assess for DVT.

Secondary objectives will be safety and accumulation. Safety will be determined by assessment of clinically significant bleeding, defined as a drop in Hgb of \> 2 grams (gm) in 24 hr, or the need for red blood cell transfusion related to bleeding. Accumulation may occur in renal failure and will be studied throughout the intensive care unit (ICU) stay through reevaluation of levels over time.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 89 years old
2. Body weight ≥ 50 kg or ≤ 150 kg
3. Estimated creatinine clearance of \< 30 mL/min
4. Predicted ICU stay of more than 72 hours.

Exclusion Criteria:

1. Pregnant women
2. Infective Endocarditis
3. Neuraxial anesthesia or spinal puncture
4. Active bleeding
5. Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin
6. Signs of disseminated intravascular coagulation
7. Severe liver failure (serum bilirubin \> 5 mg/dL)
8. Surgery planned within 24 hours of ICU admission
9. Latex allergy
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter ablation of AF. Integration of a previously acquired image of the left atrium into the electroanatomical (EA) map offers several potential advantages, including visualisation of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results . The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM, etc). Although both systems have been independently validated, their clinical utility has not previously been directly compared in a randomised trial

Patients are randomised to either NavX Fusion or Cartomerge. They undergo a standard catheter ablation procedure and data is collected. Both systems are routinely used in our clinical practise. This is a comparison trial of 2 mapping technologies.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Be undergoing their first planned procedure for electrophysiology mapping and ablation in the left atrium of AF
* Be willing and able to sign the study specific informed consent
* Have a negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria:

* Have a left ventricular ejection fraction (LVEF) of \<40% as evaluated by pre-procedure TTE
* Have any contraindication or allergy to routine procedural medications or catheter materials
* Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive electrophysiology procedure (EP) catheterisation
* Be currently participating in another clinical research study
* Have any condition for which the subject's life expectancy is less than twelve months
Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

The pathworks tissue of origin test is a microarray-based test with the goal of identifying the tissue of origin in patients with metastatic tumors of unknown primary site.


Eligibility Criteria:
Inclusion Criteria:1 Subjects must be at least 18 years old. The TOO test is designed to determine the tissue of origin of common adult malignancies. There are no gender/ethnic restrictions.

2 Patients with a diagnosis of malignancy established by pathologic review of H\&E staining of tumor biopsy or tumor resection without definitive determination of tissue of origin as assessed by the PI. Samples must have been obtained within three months of enrollment, or the patient must still be under active evaluation for tissue of origin at the time of enrollment. There are no limitations on prior therapy and time from last prior therapy.

3 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:1 Patients under the age of 18 are excluded. There are no exclusions based on gender/ethnicity.

2 There are no exclusion requirements due to co-morbid disease or incurrent illness, as needed.

3 Pregnancy or nursing participants will not be excluded from the study.

4 Patients with a diagnosis of leukemia including acute myelogenous leukemia, acute lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia and chronic lymphocytic leukemia are excluded from enrollment on this study. The TOO test does not cover these diagnoses.
Patient Education on Labor Analgesia Options

The purpose of this study is to learn how the investigators can better educate pregnant patients about the options open to them for pain relief during labor. Patients will receive educational pamphlet during prenatal clinic visit and again on admission to labor and delivery. The options for analgesia will be discussed by anesthesia care provider. Patient will be asked to complete a survey on the post partum unit.

Many analgesic options exist for laboring parturients, but labor may not be the best time to start informing patients of their options. Many patients begin the labor process with a plan in place for their analgesia. Unfortunately, internet resources regarding labor analgesia that are available to the lay parturient are poor and often lead to misconceptions about the options and their risks. A significant number of patients refuse neuraxial analgesia based on misunderstandings, concerns about the procedure, or a lack of faith in the provider. Some women want a "natural childbirth" and/or control over their labor experience. Our study aimed at providing information and alternatives for labor analgesia in a simple written format.

The investigators will provide information of available labor analgesia options (epidural, combined spinal/epidural, spinal, remifentanil patient-controlled analgesia, and intravenous opioids) to expecting mothers. Using a pamphlet written in English or Spanish disseminated to pregnant women in clinic and upon arrival in the labor and delivery unit, the procedures and their risks and benefits will be explained in simple terms. In the Labor and Delivery Unit the patients will have an opportunity to ask questions of the anesthesia care giver regarding the options for analgesia. After delivery while on F Green, patients will be asked to complete a questionnaire addressing their thoughts about the pamphlets and their overall satisfaction with their labor analgesia. The analysis will focus on the utility and effect of education materials on maternal informed consent for labor analgesia, on maternal choice of analgesia modality, and on maternal anxiety regarding their labor analgesia plan.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women ages 18 and older
* Patients who speak and read English or Spanish
* Patients who received our informational pamphlet while pregnant or in labor
* Patients who are able to consent and make medical decisions
* Patients undergoing labor or trial of labor after cesarean delivery
* Patients who undergo cesarean delivery after trial of labor

Exclusion Criteria:

* Patients unable or unwilling to complete questionnaire
* Patients unable to consent or make medical decisions
* Patients less than 18 years of age
* Patients unable to read and speak English or Spanish
* Patients in whom any of the analgesic options were contraindicated
* Patients with a history of an anxiety disorder
* Patients with precipitous labor or late presentation that precluded an analgesic intervention
* Patients with fetal distress that precluded an analgesic intervention
* Patients planned for elective cesarean section.
DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions

The purpose of this study will allow us to observe and follow the subjects' treatment from DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.

There have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. Since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* patients needed to have at least one permanent tooth with a questionable lesion. This means that subjects were at least 6 years old because that is when the permanent first molar typically erupts.

Exclusion Criteria:

* patients under 6 years old
* patients 6 years old and older who do not have a questionable lesion