cyrilzakka/clinical-trials huggingface dataset:
Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

Systemic sclerosis \[SSc\]; is a multisystem disease characterized by immune activation, microvascular disease and fibroblast dysfunction, which is thought to occur as a result of complex and not fully understood interaction between genetic and environmental factors, leading to fibrotic changes in the skin and some internal organs. It is characterized by the deposition of collagen and other matrix components in the skin and some internal organs. It has been shown by evaluating the health assessment questionnaire that it causes disability with increasing frequency over time.

Although pain cannot be localized too well to be attributed to a particular anatomical area, there are several musculoskeletal pain syndromes that can be detected in patients with systemic sclerosis. These are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and fibromyalgia. While there are several studies on others, the relationship between fibromyalgia syndrome and SSc is not known clearly. As with other connective tissue diseases, fibromyalgia is not considered to be rare in SSc.

There are a few studies on this subject. Except for one of these studies, the sensitive point in ACR 1990 FMS diagnostic criteria set was evaluated. In 2010, ACR published new criteria, which may be an alternative method in clinical practice, without sensitive points, including the common pain index and symptom severity scale. It is evaluated with the common pain index and symptom severity scale. This new set of criteria alone is not affected by pain, it is based on patient reporting. Therefore, it seems clinically more significant in determining the origin of pain in autoimmune diseases. There was only one study in the literature in which SSc patients are evaluated with the 2010 FMS criteria set . Therefore, the aim of our study was to evaluate the frequency of FMS according to 2010 FMS criteria and to investigate its effect on quality of life in our study.

Eligibility Criteria:
Inclusion Criteria:

* SSc diagnosis is definitive and diffuse involvement
* no additional disease known other than scleroderma (Diabetes mellitus, hypertension etc.)
* no known additional rheumatic diseases

Exclusion Criteria:

* To have depression and / or any psychiatric illness
* To use steroid, antidepressant, antiepileptic, regular NSAID usage.
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery:

Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.

In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block:

Group 1: neuroleptanalgesia Group 2: hypnoanalgesia Primary objective The main objective of the study is to compare changes in preoperative anxiety between the two groups, between two measurements taken preoperatively (before anxiety management) and at the end of surgery. This level will be evaluated using a VAS rated from 0 to 10.

Secondary objectives

Comparing groups:

* Intraoperative pain
* Total duration of surgical procedure, ICU stay and hospitalization
* Amount of additional sedative treatment administered during surgery
* Post-operative pain
* Patient satisfaction
* Intraoperative and immediate postoperative adverse events

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80,
* Patient who has read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes).
* Patient applying for outpatient hand surgery under LRA, such as upper limb trunk blocks (flexor teno synovectomy or endoscopic carpal tunnel surgery).
* Patient requiring sedation associated with locoregional anaesthesia

Exclusion Criteria:

* Contraindication to locoregional anaesthesia or to one of the sedatives used in the protocol
* Pregnant or breastfeeding patient or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (\> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be women after menarche and until they become post-menopausal, unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal state is defined as the absence of menstruation for 12 months without any other medical cause.
* Patient under court protection, guardianship or curatorship
* Patient not affiliated to the French social security system
* Patients unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patients, etc.
Reducing Perioperative S. Aureus Transmission Via OR PathTrac

Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly pathogenic. Isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). This project involves implementation of a software platform and bacterial collection system (OR PathTrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. We will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.

Our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on S. aureus transmission and SSIs. A multifaceted infection control program was implemented over 8 months (November 2018 to June 2019). A prospective cohort impact study was then conducted over 8 months (July 2019 to March 2020) to compare the incidence of within-case S. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients requiring anesthesia and intravenous catheter placement.

Exclusion Criteria:

* Pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.
Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement

The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing.

Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic compliance measurement was performed before and after surgery. Images were acquired with a 1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.

Observational and retrospective trial on medical data only. The patients are operated of planned aortic root aneurysm without additional intervention.

The pre and postoperative cardiac MRI are planned in standard of care.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Elective patient
* Ascending aorta replacement with graft

Exclusion Criteria:

* Prior cardiac surgery
* Contraindication to performing cardiac MRI
Increasing Physical Activity Levels in Low-Income Women

Regular physical activity is important for good health. Women, particularly women with low incomes, have many personal barriers to regular physical activity. The purpose of this study is to reduce environmental barriers to physical activity for women in two specific low-income neighborhoods (in Louisville, KY) by providing opportunities for safe physical activity and addressing barriers such as lack of child care. Two groups of women will have pretest information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight, waist and hip measurements) collected and the same information 6 months later at post-test. One group will have access to multiple physical activity opportunities in their neighborhood and at the neighborhood community center. An advanced registered nurse practitioner will facilitate the activity opportunities. The groups will be compared on their pretest and post-test information to see if the group with the physical activity opportunities has increased physical activity as measured by pedometer and self-report questionnaire, and to see if there are changes in the measures tested at pre and post (measures that may be improved by regular physical activity).


Eligibility Criteria:
live in one of two specific low-income neighborhoods in Louisville, KY
Yoga Practice for Breast or Ovarian Cancer Patients

Previous research suggests that regular physical activity may make cancer survivors do better in the long run. Laboratory studies suggest that stress may be bad for cancer patients as well. The investigators are interested in whether yoga, a practice that combines physical activity and stress reduction, is beneficial to cancer survivors. To answer that question, the investigators will need to do a large scale clinical trial.

Before the investigators can do that large study, they need to know whether people are willing to participate in this kind of study, whether they can do the yoga practice regularly and for how long, what kind of changes they may experience in how they can handle their daily activities, emotion, sleep, memory and problem solving ability, and what are the changes that can happen in their body after doing the yoga practice. Answering these questions is what this study is about.


Eligibility Criteria:
Inclusion Criteria:

* Woman age 18 or older
* History of stage 0-III breast cancer or stage I-III ovarian cancer; all antitumor therapies, excluding hormonal therapy, have been completed at least 60 days prior to enrollment
* ECOG Performance Status 0-1 (within 90 days of enrollment)
* Sedentary: \<90 minutes/week of moderate-intensity (not exhausting, light perspiration, e.g. fast walking, tennis, easy bicycling, easy swimming, popular and folk dancing) physical activity during the preceding 2 months, and \<30 minutes/month of any high-intensity activity (heart beats rapidly, sweating, e.g. running, aerobics classes, cross country skiing, vigorous swimming, vigorous bicycling) in the past 2 months

Exclusion Criteria:

* Evidence of active malignant disease
* Currently has breast implant (which limits the performance of many yoga poses)
* Significant cardiopulmonary disease, severe arthritis, glaucoma or any other medical conditions that make yoga practice unsafe as determined by a study investigator.
* Patient requires regular use of beta blockers or calcium channel blockers.
* Use of any medication that would interfere with the study's initial blood tests, including insulin or insulin secretagogues, corticosteroids, daily use of NSAIDs (except aspirin at no more than 81 mg/day) within 7 days of the initial study blood test.
* Unlikely to be compliant with the study intervention
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations


Eligibility Criteria:
Inclusion criteria:

1. Male or female patients
2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Exclusion criteria:

1. Significant history of allergy/hypersensitivity
2. Hypersensitivity to study drug
3. Participation in another trial
4. Female patients who are pregnant or lactating
5. Female patients of childbearing potential
6. Patients who have started a new medication for CF within 4 weeks of screening
7. Patients with known substance abuse
8. Clinically significant disease other than CF
Ongoing WARfarin and Coronary STENTing

Patients on warfarin treatment pose particular problems when undergoing percutaneous coronary intervention with stent implantation (PCI-S), because of the poor definition of the optimal antithrombotic strategies to be adopted both peri-procedurally and during the 4 (or more) weeks after PCI-S, when dual antiplatelet therapy with aspirin and clopidogrel is recommended. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. Indeed, a high variability has been reported in the current antithrombotic strategies, which may consist in either the temporary substitution of warfarin by dual antiplatelet treatment or the combination of warfarin and aspirin or clopidogrel or both. Peri-procedural bridging therapy with either intravenous unfractionated or subcutaneous low-molecular-weight heparin is also variably carried out. Purpose of this registry is to determine in patients on warfarin treatment undergoing PCI-S: 1) the contemporary peri-procedural and medium-term antithrombotic management; and 2) the relative safety and efficacy of the various antithrombotic regimens.

Patients on oral anticoagulation with vitamin-K antagonists who undergo PCI-S will be prospectively included in the registry and follow up for 12 months

Eligibility Criteria:
Inclusion Criteria:

* Patients with ongoing warfarin treatment.

Exclusion Criteria:

* None
Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health

The purpose of the present study is the assessment of the mental health and cognitive development of children 6-11 years after premature or term birth. Impairments in children's' mental health are assessed focusing different disorders or problems (ADHD, Autism traits, Affective disorders, oppositional-aggressive behavior) and using both questionnaires and a clinical interview. Risk and protective factors will be analyzed, e.g., threat and/or actual premature birth compared to term birth, parents' mental health, positive coping, personality traits and social support in the peripartum period and afterwards, as well as medical parameters. The potential interaction of premature birth, medical complications, parental distress and children's mental health will be taken into consideration.

A follow-up survey is conducted based on a previous study on psychological distress in parents with preterm infants (NCT01974531). Medical records and previous questionnaire data will be used for grouping the children based on threat of preterm birth, actual preterm birth and term birth as well as to assess the risk and protective factors in the peripartum period.

Parents have been informed within the first study part that a second study part, including their children, would have been followed. Parents were recontacted and asked for participation via telephone or email. Those who agreed, will be contacted via questionnaires in a first step and then in a second step interviewed regarding their own and their children's mental health. The investigators use the following questionnaires to assess children's mental health: Child Behaviour Checklist 6-18R (CBCL 6-18R), Conners 3rd Edition, Social Communication Questionnaire (SCQ), Revised Children\&#39;s Anxiety and Depression Scale (RCADS). In addition, the investigators conduct clinical interviews with parents on their children's mental health and assess children's cognitive competencies using the Wechsler Intelligence Scale for Children (WISC-V). The following questionnaires are used to assess parental risk and protective factors: State-Trait Anxiety-Depression Inventory (STADI), Parental Stress Scale (PSS), Parenting Scale Short Form (PS), Big Five Inventory Short Form (BFI).

Eligibility Criteria:
Children and their parents must have participated in the previous study. Inclusion criteria of the previous study regarding the parents were:

* Pregnant women and their partners from the 24th week of gestation on
* 18 years of age

Exclusion criteria of the previous study were:

* Psychiatric, mainly psychotic diseases
* Drug abuse
* Severe neurological disorders
* Stillbirth
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy.

PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.

OBJECTIVES:

* To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration.
* To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods.
* To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors.
* To establish a skin cancer tissue bank.

OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm
* No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known hypersensitivity to aminolevulinic acid or any component of this medication

PRIOR CONCURRENT THERAPY:

* Concurrent immunosuppressive or chemotherapeutic medications allowed
* Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed
* Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed
* Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed
* No concurrent participation in another clinical trial
* No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers
* No concurrent medical therapy or radiotherapy for other cancers
Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic Mothers

In this study, the investigators have aimed to investigate whether GDM is a risk factor for hearing impairment in newborns. To the investigators knowledge, this study is the first prospective, controlled study on this subject.

Gestational diabetes mellitus (GDM) is an increasingly frequent condition in the world causing significant morbidity and mortality. GDM is a metabolic disease that develops in pregnancy, and may result in complications in the pregnant women, similar to other patients with diabetes. The prevalence of GDM varies in relation with the population and the diagnostic criteria. Diabetes affects 6-9% of pregnant women; 99% of the cases have GDM, and diabetes is diagnosed before pregnancy in the remaining 1% \[(pre-gestational diabetes mellitus (pre-GDM)\]. Hearing loss is one of the most common birth defect in newborns. The incidence of congenital hearing impairment is 2-3 per 1000 births. Early diagnosis and treatment is very important for the development of auditory pathways and protection of cognitive functions. Therefore, newborn hearing screening programs have been in use in a number of countries. Transient evoked otoacoustic emissions (TEOAE) and auditory brainstem response (ABR) have been identified as basic convenient and applicable tools for neonatal screening of hearing.

Suboptimal glycemic control during pregnancy has adverse fetal effects. Congenital malformations, preterm birth and neonatal respiratory distress in the newborn are more common, at varying rates, pre-GDM and GDM. Compared to the normal population, the risk of congenital malformations is 1.9-10 fold higher in presence of pre-GDM, and 1.1-1.3 fold higher in presence of GDM. Despite our awareness on these important complications, the effect of intrauterine hyperglycemia on hearing of the newborn has not yet been studied in detail. Diabetes mellitus (DM) often causes hearing impairment, however little is known whether GDM is an antenatal risk factor for cochlear damage and hearing loss.

Eligibility Criteria:
Inclusion Criteria:

* Women with gestational diabetes
* Women without diabetic pregnancy

Exclusion Criteria:

* Admitted to the neonatal intensive care unit for more than five days
* Perinatal asphyxia
* Craniofacial abnormalities
* İntrauterine infections
* Hyperbilirubinemia requiring exchange transfusion
* Very low birth weight (\<1500 g)
* Gestational hypertension
* Preeclampsia