cyrilzakka/clinical-trials huggingface dataset:
Efficiency of Patient Blood Management Protocol in Gynecological Surgery Department (PERIOPESGYNECO)

Perioperative anemia is associated with higher risk of red blood cell transfusion, higher rates of morbimortality and lower quality of postoperative recovery. In a context of focussing on higher quality management and improved recovery after surgery, development of Patient Blood management has increased. This study aim to assess PBM protocole in a postoperative context of gynaecological surgery, by comparing indicators at two time periods: 2 and 8 months after establishment of PBM protocol.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* being hospitalised for planned hysterectomy or cancer related ovariectomy

Exclusion Criteria:

* less than 18 years
* non french speaker
* being under a legal individual protection measure
* not being able to consent
* being opposed to data collection
The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery

The purpose of this study is to identify measures of obesity, functional capacity, and specific biomarkers that may be predictive of obesity and post-operative outcomes.

Background: Increasing levels of obesity worldwide have led to a rise in the prevalence of obesity-related complications including cardiovascular disease, diabetes, cancers etc. Health care providers believe that obesity has a negative effect on patients undergoing cardiac surgery, with overweight and obese patients being more likely to experience adverse post-operative outcomes. The body mass index (BMI) is the single most used measure for determining obesity classification in clinical practice, without accounting for a patient's level of cardiopulmonary fitness or muscle mass.

Study Design: Patients between the ages of 18 and 75 years undergoing elective cardiac surgery will be consented to participate in this prospective observational trial. Patients are invited to participate in measures of obesity, functional capacity and exercise capacity assessments, quality of life questionnaires, and blood and tissue sampling for biomarker analysis.

Endpoints: Measures other than BMI that could be predictive of short-term and long-term post-operative outcomes. Outcomes of interest include: prolonged length of ventilation, hospital length of stay and all-cause mortality.

Summary: The results of this trial will potentially identify an improved definition of fitness capacity for obese cardiac surgical patients and biomarkers alone or in combination that could identify the potential for adverse outcomes in patients undergoing cardiac surgery. This study will help clinicians better segregate and treat patients pre-operatively based on fitness levels and associated biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* · Provide informed consent

  * Male or female patients who are \> 18 years of age
  * Patients must be scheduled to undergo elective, first-time cardiac surgery during routine scheduling times

Exclusion Criteria:

* Patients who are \> 75 years of age
* BMI is less than 18.5 kg/m2 and classified as underweight according to the World Health Organization
* Any non-elective first time cardiac surgery patient (eg. in-house urgent patients; emergent patients)
* Any cardiac patients to undergo re-operation
* Simultaneous participation in another study with an investigational study agent
Real-Life Passive Exposure Assessment of IQOS

This study is a non-interventional observational study designed to assess the impact of passive exposure to IQOS environmental tobacco aerosol in Non-Smokers in a real-life restaurant setting.

The purpose of the study is to show that Non-Smokers, exposed to environmental tobacco aerosol from IQOS in a restaurant setting, do not have higher urinary levels of Biomarkers of Exposure (BoExp) to selected Harmful and Potentially Harmful Constituents (HPHCs), representative of Environmental Tobacco Smoke (ETS), compared to the urinary levels of BoExp measured in Non-Smokers before IQOS environmental tobacco aerosol exposure.

Furthermore, the impact of passive exposure to IQOS environmental tobacco aerosol on IQOS Users and Cigarette Smokers, not using any tobacco or nicotine-containing products, will be investigated. This will enable the assessment of individuals with varying levels of exposure to HPHCs and determine whether there is any measurable additional exposure related to the environmental tobacco aerosol from IQOS.

The study will also evaluate Indoor Air Quality (IAQ) through the assessment of concentrations of nicotine and selected HPHCs representative of tobacco-specific and IAQ markers in the air during exposure and non-exposure periods in a real-life restaurant setting.

Eligibility Criteria:
Inclusion Criteria:

* Participant is able to understand the information provided in the Subject Information Sheet (SIS) and Informed Consent Form (ICF) (confirmed by signing the ICF) and has signed the ICF.
* Adults legally authorized to buy tobacco products in Japan (20 years of age).
* Participant is Japanese as self-reported.
* Willing to participate in the study, comply with study procedures and has access to the Internet.
* Participant is an active IQOS User, Cigarette smoker or Non-Smoker as self-reported

Exclusion Criteria:

* Participant with a medical history of severe cardiovascular or respiratory diseases (e.g., stroke, acute cardiovascular event, pulmonary thrombosis) in the last 12 months as self-reported.
* Participant with currently active cancer or history of cancer within the last 5 years as self-reported.
* Female participant who is pregnant or breast-feeding as self-reported.
* Participant is a current or former employee of the tobacco industry or their first-degree relatives (parent and child).
* Participant is an employee of Philip Morris International (PMI), an employee of the Contract Research Organization (CRO) engaged for this study, an employee of the CRO's vendors, an employee of the restaurant/event location, or their first-degree relatives (parent or child).

Exclusion criteria specific to participants who are Non-Smokers:

* Participant lives in a household with users of tobacco or nicotine-containing products, or is exposed to the use of tobacco or nicotine-containing products at the workplace.
Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease

Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants that are present in many natural food sources may provide protection from such damage.

Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae Dunaliella is particularly rich in beta carotene.

In this prospective trial we want to investigate whether beta carotene from Dunaliella may prevent exacerbations of Crohn's disease.

Patients with documented Crohn's disease who are at least 2 months in remission (CDAI\<150) will be randomized to receive 60 mg beta carotene/day vs. placebo for 1 year.

The study medication will be taken in addition to regular treatment for Crohn's disease.

The protocol includes 5 visits (months 0, 3, 6, 9, 12). Each visit lasts 30-60 minutes and includes a brief interview, standard questionnaires, physical examination, and blood tests.

Exacerbation of Crohn's disease is defined as CDAI\>150. The study hypothesis is that less patients treated with beta carotene will suffer an exacerbation than patients treated with placebo.

Eligibility Criteria:
Inclusion Criteria:

* patients with documented Crohn's disease in remission (CDAI\<150) for at least two months, age 17-75 years

Exclusion Criteria:

* active Crohn's disease (CDAI\>150), partial bowel obstruction, impending surgery, pregnancy, serious other diseases
Investigation of the Effects of Core Exercises Performed on Stable

The popularity of core stability and strengthening exercise programs in physical rehabilitation and fitness practice, which has become popular since the 20th century, is increasing day by day. The purpose of this research is to reveal the effects of core stability and core strength exercises performed on stable and unstable ground on selected skills.

Scientific studies have shown that there is no clear view on the effects of core exercise models applied on different surfaces, and there are very few studies that observe performance increases in sports activities. Based on this, the aim of this study is to understand more clearly the effects of core stability and core strength exercises performed on stable and unstable ground on selected skills and to implement more functional training programs accordingly. Thus, it is assumed that core training will provide strong positive effects on performance in both athletic and daily activities.

Methods A total of 31 young individuals aged between 18-23, studying at Malatya Inonu University Faculty of Sports Sciences and without any health problems, were included in the study. Participants were divided into three groups: Stable Ground Group (SGG), Unstable Ground Group (USGG) and Control Group (CG). SGG and USGG exercise participants participated in a core exercise program for a total of 25-30 minutes, 2 days a week for 5 weeks. SGG participants performed exercises on a stable floor surface, while USGG participants completed the exercise program on a bosuball. . CG did not participate in any exercise program. CG continued their daily routine activities and maintained their current physical activity levels. The testers were blind to the group (control or training) each subject allocated to. At the end of the exercise protocol, the same procedures applied for the pre-test were applied for the post-test measurements. All tests were performed in an indoor sports hall. All data obtained were recorded on a form created specifically for the study.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy,
* Having never done core exercise before,
* Being 18 years old or older,
* Being a volunteer

Exclusion Criteria:

* Having any injury,
* Not participating in the core training program regularly in this study,
* Being injured during the training application phase.
Manipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome

Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program for lower thoracic and cervical spine.

Study Design: A single-blind randomized controlled trial was conducted on patients with fibromyalgia syndrome (FMS).

Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving manipulative and massage therapy, or to a control group for exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Fibromyalgia Syndrome.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions.
* Non-practice of regular physical activity.

Exclusion Criteria:

* A history of surgery.
* The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis).
* A history of whiplash injury.
* Severe physical disability.
* Uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes).
* Illness (e.g., schizophrenia or substance abuse).
* The use of medication other than as-needed analgesics (excluding long-term narcotics).
* Malignancy.
* Psychiatric disorders.
* A score of ≥ 9 points in the Beck depression inventory.
Epidemiology of Coronary Calcification in the Elderly

To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls.

BACKGROUND:

This is an ancillary study to the Systolic Hypertension in the Elderly Program (SHEP)

DESIGN NARRATIVE:

Continued annual telephone follow-up of the remaining 178 Pittsburgh SHEP participants and 168 controls will be conducted . A final clinic visit will include measures of coronary and aortic calcification using electron beam computed tomography (CT), pulse wave velocity as a measure of aortic stiffening and cognitive function testing. For the Pittsburgh SHEP cohort, the antihypertensive treatment effect has been striking with event rates for the active and placebo groups continuing to diverge beyong the end of SHEP. Successful demonstration of a treatment effect on coronary calcium scores would be the first randomized data showing an antihypertensive effect directly in the coronary arteries. Risk factors for coronary calcification will be evaluated, producing data of a type not yet available in the literature for older adults and not being collected in any other ongoing studies of the elderly. The added measures of vascular stiffness will supplement the extensive data on subclinical atherosclerosis already available for this cohort. The extent to which these measures predict cardiovascular events will be evaluated. The study has been renewed through July 2006.

Since hypertension and aging are associated with cognitive impairment and vascular dementia, SHEP participants assigned to the placebo group are expected to have lower cognitive function compared to those assigned to active treatment. Among both hypertensive and normotensive groups, lower cognitive function among those with evidence of subclinical atherosclerosis is expected.

Finally, members of the cohort who were originally normotensive at study entry are now developing systolic hypertension. These subjects will allow a prospective evaluation of risk factors for systolic hypertension. Continued study of this cohort into their 80s will provide unique data on the risks and etiology of systolic hypertension, the efficacy of its treatment and the prognostic value of a number of measures of subclinical atherosclerosis. It is predicted that the results will be directly applicable to the largest growing segment of the U.S. population.

Eligibility Criteria:
Participating in the Cardiovascular Health Study (CHS) at the University of Pittsburgh Site.

Inclusion criteria:

Age 65 or older in 1989-90 Able to give informed consent Able to travel to study site No plans to move from the area within 3 years of CHS enrollment

Exclusion criteria:

Inability to give informed consent at time of EBCT scan Unable to travel to study center Lives in nursing home.
Effects of SCALP Block on Postoperative Analgesia in Craniotomy Surgery

Patients undergoing craniotomy surgery often experience severe postoperative pain. This pain can affect the patient's hemodynamics, disrupt sleep patterns, and prolong hospital stays. Sudden increases in heart rate and blood pressure due to pain may lead to elevated intracranial pressure in patients, potentially causing morbidity and mortality. Opioids are commonly used to mitigate hemodynamic fluctuations and reduce postoperative pain; however, they may delay recovery, contribute to excessive sedation, and affect postoperative neurological examinations. Additionally, opioids have adverse effects such as nausea, vomiting, and respiratory depression. Alleviating hemodynamic instability and postoperative pain are critical concerns for neuro anesthesiologists. Regional analgesia techniques are employed in neurosurgery patients because they minimize anesthesia requirements, alleviate pain, and allow for neurological assessment with a lower incidence of systemic complications.The scalp block was developed due to its potential benefits as an effective regional anesthesia technique that supports the advancement of delicate brain surgeries such as functional and microsurgeries.

In this study, we hypothesize that patients who receive a SCALP block will have lower postoperative Numerical Rating Scale scores and consume less total analgesia.

Our primary objective is to evaluate postoperative numerical rating scale scores in patients undergoing craniotomy surgery with a SCALP block.

Our secondary objectives are to assess the total amount of rescue analgesia consumed, the time to first rescue analgesia, patient satisfaction, and any possible complications. The study was planned as a prospective, randomized, controlled, double blind. At each clinic, an anesthesiologist randomly allocated patients to two significant groups using numbered opaque sealed envelopes: Group S (patients receiving SCALP block) and Group C (patients getting just multimodal analgesia). The anesthesiologists responsible for the randomization process were not involved in any other sections of the trial, and the individuals executing the SCALP blocks procedure were not engaged in other areas of the research. Additionally, the researcher who intervened, the participants, and the analyzer were blinded to the details of the study. After the surgery, two different anesthesia technicians recorded the primary and secondary results of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* General anesthesia
* American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* Contraindications to regional anesthesia
* Coagulation disorders
* Known allergy to local anesthetics
* Infections at the block site
* Pregnant patients
* Emergency cases
Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.

To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.

Eligibility Criteria:
Inclusion Criteria:

* children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones suitable for ureteroscopy.

Exclusion Criteria:

* Fever, pyonephrosis or sepsis.
* unstable patients are stabilized first by dialysis.
Impact of the Information Follow-up Given to Patients on Their Disease Understanding and Therapeutic Adherence in Patients Under Direct Oral Anticoagulants and With Atrial Fibrillation in a Cardiology Department

The primary objective of this study is to measure in patients addressed for Atrial Fibrillation (AF) in the Cardiology-Electrophysiology and Cardiac Stimulation Department of Bordeaux hospital, the impact of a specialized nurse consultation on their adherence level to direct oral anticoagulants treatments.

The number of persons that should take an anticoagulant treatment in France is evaluated at 3 Billion and at least half of them for an Atrial Fibrillation disease. One of the main issues of their prescription is stoke prevention. With the coming of direct oral anticoagulants, which does not require repeating controls like it is the case for anti-vitamin K treatments, the patient's involvement is a guarantee of therapeutic adherence and good use. Nevertheless a good adherence level is seldom reached. This highlights the importance of individualized information which must be followed for purposes of accuracy and deepening. Thus as part of investigator's activity department that treats about 1000 patients per year for an Atrial Fibrillation, the information, use and therapeutic adherence are a priority in the care pathway of patients under direct oral anticoagulants. The investigators propose to measure the contribution of a specialized nurse consultation in contact with a multidisciplinary team on therapeutic adherence. The investigators hypothesis that an individualized and reassessed information would allowed a better understanding by the patients of their pathology and care and thus a better therapeutic adherence. A control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation. The second group will benefit of a specialized nurse consultation throughout of which an individualized information will be delivered. This information will be reevaluated during the usual patient follow-up. All the patients will be followed at 3 months, 6 months and 1 year as part of the usual care of the service.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in the Cardiology-Electrophysiology and Cardiac Stimulation Department for an AF,
* Patient requiring direct oral anticoagulant treatment,
* Age ≥ 18 years of both genders,
* Written consent,
* Patient affiliated or beneficiary of a social insurance,
* French language.

Exclusion Criteria:

* Patient unable to give his written consent or with cognitive disorders,
* Patient depending of a third person,
* Patient unable to be followed in the service,
* Patient in exclusion period for another protocol,
* Subject deprived of liberty by judicial or administrative decision,
* Protected adults,
* Non-inclusion criteria specific to direct oral anticoagulants (valvular AF, severe renal impairment).
The Effects of a CONCOR Smartphone Application

Life expectancy of children with congenital heart disease (CHD) has increased dramatically during the past years, due to the successes of cardiac surgery. Nearly all of these children with CHD can be operated at young age and more than 90% reach adulthood. However, many adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. These events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult CHD. Especially for adults with CHD patient care with a smartphone is suited because of their young age and chronic condition. So far, data are lacking on smartphone interventions in patients with CHD.

The investigators aim to determine feasibility of CONCOR smartphone application management in adults with CHD. Moreover, during a twelve months follow up period the investigators aim to evaluate whether management with a CONCOR smartphone application results in a lower rate of heart failure events and arrhythmia as well as a better quality of life than usual care, because of increased patient awareness, behavioral stimuli, healthy life style reminders and more precise medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults with CHD being an Academic Medical Center (AMC) patient and/ or patients registered in the Dutch CONCOR registry
* Owning a smartphone

Exclusion Criteria:

* Mental retardation and/ or Down syndrome