cyrilzakka/clinical-trials huggingface dataset:
Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients

Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV.

The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.

In a recent study (Triverio PA et al. "Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in haemodialysis patients". Nephrol Dial Transplant 2009; 24: 1952-6), the investigators had compared 2 IGRAs (T-SPOT.TB and Quantiferon Gold) with the TST and shown that one IGRA was clearly more sensitive than the TST but that both tests had a very low sensitivity for detecting prior TB.

This study applies the same protocol to renal transplant recipients undergoing routine annual check-up visits: questionnaire with detailed collection of risk factors for latent tuberculosis infection (LTBI), history of prior contact with tuberculosis (TB), BCG (Bacille of Calmette and Guerin vaccine), prior TB or LTBI, treatment for TB or LTBI, analysis of chest X-ray for signs of prior TB, on-going treatment, level of immunosuppression (CD4 lymphocytes), simultaneous blood sampling for T-SPOT.TB and Quantiferon Gold, and tuberculin skin testing.

Eligibility Criteria:
Inclusion Criteria:

* prior renal transplantation;
* age \> 18;
* stable clinical condition

Exclusion Criteria:

* hypersensitivity to tuberculin skin testing
Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)

Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up.

Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients.

At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.

Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index \>200 or a specimen with atypical or neoplastic cells).

Exclusion Criteria:

* Other surgery within 30 days (except surgery in local anaesthesia).
* Chemotherapy within 3 months.
* Inability to give informed consent.
* Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
Prevalence of Chondromalacia Patella Among Adolescent Dancers - Correlation Between Symptoms and Sonography Findings

Comparing the physical and sonographic findings of dancers with Chondromalacia patella to non-dancers athletes.

A cross sectional study in which comparing of dancers to non-dancers athletes will be carried. Specifically, chondromalacia patella will be studied and compared between dancers with and without knee injuries and non-dancers athletes.

Study will include detailed function and pain questionnaires, physical findings and sonographic study of the knee joint.

Eligibility Criteria:
Group A - Dancers with knee injury:

Inclusion Criteria:

1. Min. 3 hours of classic ballet dancing per week
2. At least 4 years of dancing practice
3. Reported knee pain during the last 6 months

Exclusion Criteria:

1. Injury other than knee joint

Group B - Dancers without knee injury:

Inclusion Criteria:

1. Min. 3 hours of classic ballet dancing per week
2. At least 4 years of dancing practice
3. Reported no musculoskeletal injury during the last 6 months

Exclusion Criteria:

1. None

Group C - Non-dancers athletes:

Inclusion Criteria:

1. Main physical activity is other than dancing

Exclusion Criteria:

1. Reported no musculoskeletal injury during the last 6 months
Social Media as an Information, Education and Communication Tool for Rabies Prevention: An Interventional Study

Background: Rabies is a fatal disease that can be avoided by treating animal bites promptly. Hence, post-exposure prophylaxis is critical. As a result, the National Rabies Control Program was approved under the 12th five-year plan in India. One of its strategies is to engage in Information, Education and Communication activities. Social media provides an opportunity for the quick and easy dissemination of research but is constrained by a lack of peer review and the risk of misinterpretation. The efficacy of a novel social media-based knowledge dissemination strategy for rabies prevention was tested in this study.

Methods: An experimental study design was followed, wherein 144 preclinical medical students of Maulana Azad Medical College, Delhi, India were included in each control and test group. The test group was administered the intervention, which exposed the participants to health education material via social media across a span of 30 days. Participants' knowledge, attitude and practices were observed before and after the study duration.


Eligibility Criteria:
Inclusion Criteria:

* adult individuals who have a smartphone, internet access and are WhatsApp users
* preclinical medical students, i.e., Bachelor of Medicine, Bachelor of Surgery (MBBS) 1st and 2nd professional year students

Exclusion Criteria:

* individuals who themselves have been a dog bite or rabies victim
* individuals who have a dog bite or rabies victim in the household
* individuals who developed the above criteria during the study duration were excluded from the data analysis
Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy

The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.

Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective analgesia after hysterectomy essential and several techniques are used such as administration of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local anaesthetics. Different local anaesthetics can be used for the wound infiltration techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides pain relief in the postoperative period , allows the early discharge from the outpatient surgical units.There has been increased interest in administration of analgesic prior to surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine has been used intravenously before initiation of anaesthesia and it has shown to provide some analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic effects of intravenous administration while still providing the postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 yo female
* scheduled for elective hysterectomy
* no known allergies to drugs
* ASA 1=2 patients

Exclusion Criteria:

* history of diabetes
* history of chronic pain treatment
* pregnancy
Robot-Assisted Pyeloplasty in Young Children

The goal of this retrospective study is to analyse the outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old:

* indication criteria
* clinical symptoms
* operating time
* length of stay
* complications
* follow-up

Outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old and comparison with the outcomes in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

Exclusion Criteria:

* Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022
Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment.

With evidence linking surgical morbidity to hyperglycemia (high blood sugar), attention to glucose control is warranted during surgery as well as in the postoperative period. Consequently, measures to prevent and treat hyperglycemia - coupled with fasting status - places patients at considerable risk for perioperative hypoglycemia (low blood sugar). Outpatient patient studies support that profound hypoglycemia can be deleterious and even fatal to patients.

This descriptive study will utilize retrospective chart review to examine factors associated with hypoglycemia. Charts from 700 subjects who experienced blood glucose values less than 70 mg/dl primarily in the preoperative and postanesthesia care units at William Beaumont Hospital-Royal Oak will be reviewed. Another 1600 charts will be screened for subsequent intraoperative hypoglycemia: 800 that had low normal preoperative glucose values and 800 that had high preoperative values (with likelihood of insulin therapy).

Numerous factors believed to be associated with perioperative hypoglycemia will be analyzed including type and duration of diabetes, usual diabetes treatment regimen and alterations on day of surgery, self-reported usual fasting blood sugar range, duration of fasting, type of surgery and anesthesia, co-morbidities, and medications associated with hypoglycemia.

Determining factors associated with perioperative hypoglycemia will improve prediction of which patients are at highest risk for hypoglycemia, enabling healthcare providers to institute more conservative insulin therapy when indicated, initiate early maintenance intravenous dextrose, and/ or perform more frequent glucose testing. Identifying associated factors will improve hypoglycemic predictions and interventions which should lead to safer, more effective care for patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgery at William Beaumont Hospital in Royal Oak, Michigan between January 1, 2003, and January 1, 2009.
* Point of care testing identified a blood sugar value less than 69 mg/dl at any time in the perioperative area; or a value between 70-89 mg/dl in the preoperative area; or a glucose value greater than 250 mg/dl in the preoperative area.

Exclusion Criteria:

* Obstetric patients.
Effects of Exercise Training and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep

The objective is to investigate the effects of exercise training in hypertensive individuals with obstructive sleep apnea (OSA) in neurovascular control taking into account genetic factors. Seventy-two hypertensive patients with OSA \>15 events/hour of sleep revealed by nocturnal polysomnography will be randomized into a control or physical training group. All will be evaluated for the T786 genotypes of the eNOS gene gene. The study will investigate the effect of the exercise program on vascular control in different alleles of the T786 genotypes of the eNOS gene.

Experimental Design. All participants underwent overnight polysomnography study. The apnea-hypopnea index (AHI) will be calculated by total number of respiratory events (apneas and hypopneas) per hour of sleep. Obstructive sleep apnea will be defined as a cessation of respiratory airflow for 10 seconds with thoracoabdominal effort, which was detected by Piezo respiratory effort sensor. Individuals with \>70% of obstructive events were defined as individuals with OSA.

Muscle blood flow will be evaluated by pletismography tecnique.

Heart rate and blood pressure. Heart rate (HR) was beat-by-beat continuously measured during the test obtained in a computer-recorded electrocardiographic tracing. Blood pressure (BP) was monitored noninvasively from an automatic leg blood pressure cuff (nondominant leg) using automated oscillometric device. The systolic, diastolic and mean blood pressures will be registered.

Cardiopulmonary Exercise Test. Maximal exercise capacity was determined by means of a maximal progressive cardiopulmonary exercise test Peak VO2 will be defined as the maximum attained VO2 at the end of the exercise period in which the subject could no longer maintain the walk velocity.

Eligibility Criteria:
Inclusion Criteria:

* sedentary,
* Hipertensive patients

Exclusion Criteria:

* Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease
The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)

The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with age-related macular degeneration.

Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.

Eligibility Criteria:
Inclusion Criteria:

* have a clinical diagnosis of GA in one or both eyes;
* be of non-childbearing potential

Exclusion Criteria:

* have GA secondary to any condition other than AMD in the study eye;
* have a BCVA of 20/200 or worse in the non-study eye;
* have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy;
* have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study;
* need to wear contact lenses in the study eye during the study;
* had confounding ocular surgery in the study eye;
* have concomitant treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, or optic nerve;
Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

The study investigators hypothesize that SARS-Cov2 infection alters the composition of the digestive microbiota and its functionality, resulting in changes in intestinal permeability and consequently in microbial digestive translocation. These changes may correlate with the magnitude of the SARS-CoV-2 viral load in the gastrointestinal tract and may have an impact on the clinical manifestations and evolvability of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized at in Nimes University hospital
* Infection with SARS-CoV-2 confirmed by RT-PCR
* The patient must have signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in an interventional study susceptible to modify the intestinal microbiota, or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient with a chronic digestive pathology or having been operated in the previous year or having enteral nutrition or having had bariatric surgery
* Patient is pregnant, parturient or breastfeeding
Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss

The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).


Eligibility Criteria:
Inclusion Criteria:

* Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
* Symmetric hearing prior to onset of SSHL
* Enrollment has to be accomplished within 7 days after SSHL onset

Exclusion Criteria:

* Bilateral SSHL
* Incomplete recovery after previous SSHL
* Previously existing, known retrocochlear hearing loss
* Any history of any ear operation or local inflammatory disease in the past one year
* History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
* History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
* Treatment with steroids for any reason within the preceding 30 days.
* Body weight \> 140 kg
Sedation Regimens in GI Endoscopy

This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking patients
* Patients ≥18 years old and ≤75 years old
* Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl
* Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure

Exclusion Criteria:

* Patients with an allergy or prior adverse event to either fentanyl or midazolam
* Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC)
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent
Effectiveness of Mindfulness-based Stress Reduction Program

Having a physically disabled child presents serious challenges for parents, not only in the practice of daily living, but also on a psychological and emotional level. In addition to meeting the constant and complex needs of their children, these parents must also maintain their own emotional balance and psychological well-being. In the long term, high stress levels can seriously compromise parents' mental health and reduce their overall quality of life. Therefore, the development of effective stress management strategies and psychological support mechanisms for parents is critical not only for individual well-being but also for the health of family relationships. Mindfulness practices, in this context, emerge as powerful tools with the potential to increase parents' ability to cope with stress and improve emotional well-being. Therefore, this study aims to determine the effect of the mindfulness stress reduction program applied to parents of physically disabled children on stress and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Being able to read and write
* Having a child diagnosed with a physical disability

Exclusion Criteria:

* Having more than one physically disabled child
Prospective, Longitudinal Multicentric Survey in the Therapeutic Care of Mild to Moderate Ulcerative Colitis

The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above
* Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis)
* Having received the information sheet

Exclusion Criteria:

* Participating, at the time of inclusion, in another study using an investigational drug or device
Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation

Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD incidence. Furthermore it will allow shortening of the length of post-transplantation immunosuppression with calcineurin inhibitor (CNI) administration (currently administrated in addition to ATG as GVHD prophylaxis in daily common practice)


Eligibility Criteria:
Inclusion Criteria:

1. Patients with MDS/AML
2. 18 years or older and willing and able to comply with the protocol requirements.
3. LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
4. Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation
5. Patients conditioned with reduced intensity or reduced toxicity conditioning of fludarabine with reduced dose (2 days) or myeloabalative doses (4 days) of busulfan or with treosulfan.
6. Patients must sign written informed consent.
7. Adequate birth control in fertile patients.

Exclusion Criteria:

1. Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.
2. Patients with respiratory failure (DLCO \< 30%).
3. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
4. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
5. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
6. Creatinine \> 2.0 mg/dl
7. ECOG-Performance status \> 2
8. Uncontrolled infection
9. Pregnancy or lactation
10. CNS disease involvement
11. Pleural effusion or ascites \> 1 liter.