cyrilzakka/clinical-trials huggingface dataset:
Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients

Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are the most affected group. IA has a very high morbimortality due to its rapid progression and because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an early stage: detection of Galactomannan antigen of Aspergillus species and real - time polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is mainly located in lungs, so our hypothesis is that in patients where the investigators suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection could be useful for diagnosis.

Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility.

Methods: Prospective study. The investigators will include 200 patients. 100 of them will be hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be patients without risk or no suspicion at all of IA. The investigators will perform a BAL in all patients. And blood detection of Galactomannan Antigen in hematological patients. The investigators will perform a standard microbiological culture of BAL and Galactomannan Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.

Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in BAL with more specificity and making earlier diagnosis than in blood. The investigators also expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic patients.


Eligibility Criteria:
Inclusion Criteria:

* 100 BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion.
* 100 BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason.

Exclusion Criteria:

* Patients without fulfilling inclusion criteria.
* Patients with some contraindication to perform a bronchoscopy.
High-Resolution Anoscopy Perceived Discomfort Study

Study should determine if performing the less uncomfortable part of the exam (the perianal exam) results in less recalled discomfort if performed last vs. if performed first.

Performance of the perianal examination at the end of the high resolution anoscopy (HRA) procedure will lead to patients reporting less discomfort directly following the procedure. The study team hypothesizes at least a 10% decrease in subsequently rated pain scores in the group where the perianal exam is performed last compared to the group where it is performed first.

Eligibility Criteria:
Inclusion Criteria:

* Present for a previously scheduled high resolution anoscopy procedure
* Able to participate in an English written survey following the HRA procedure

Exclusion Criteria:

* Undergoing ablation during the HRA procedure
* Inability to tolerate or complete the HRA procedure
* Unwillingness or inability to complete the post-procedure survey
* Previous participation in the study
Bone Microarchitecture in Young Cystic Fibrosis Patients

Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age. Recent data from our center and others have suggested that low BMD could be observed very early in life. However, quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).

High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology with very high spatial resolution. Images obtained with this technic are considered as virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces exploration in a three-dimensional manner, and therefore provides informations on bone microarchitecture as well as bone density.

The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.


Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis patient of both sex
* Pubertal patient
* Age ≥10 years and ≤18 years on the date of informed consent
* FEV1(forced expiratory volume at one second ) ≥ 60% of predicted normal for age, gender and height
* Patient on a clinical stable period

Exclusion Criteria:

* Unable to maintain arm and/or leg immobile for 3 minutes
* History of solid organ transplantation
* Participation in the same time to a clinical trial
* Acute pulmonary exacerbation at the time of evaluation
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)

It has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 27
* 20-55 years
* healthy

Exclusion Criteria:

* diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
* prescription medications affecting the metabolism of glucose, lipids or the immune system
* use of supplements containing long chain n-3 fatty acids
* high intake of fish
* food allergy
Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease

The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in patients with peripheral arterial occlusive disease.

First, the original version of WIQ will be translated into Korean, then it will be translated into English, again. The translated version will be sent to the original author to compare with the original version. After correcting, the Korean version will be completed.

The patients with peripheral arterial disease will fill in the Korean version of WIQ before starting treatments. Baseline results of arterial function test, toe-brachial index and treadmill test will be recorded. Three months later, the patients will complete the questionnaire again. Arterial function test, toe-brachial index and treadmill test also will be taken again after treatment and the correlation of WIQ and other exams will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 19\~ 80 years
* claudication
* Ankle brachial index \< 0.9 or TBI \< 0.7 (in patients with DM and ABI higher than 1.3)
* patients who can complete the treadmill test (slope 12%, 2.4km/hr)

Exclusion Criteria:

* critical limb ischemia
* Ankle pressure \< 40mmHg
* claudication due to other causes (i.e. spinal stenosis, arthritis, etc)
* patients with high risk of coronary artery syndrome during treadmill test
Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study

A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Unfortunately, there is currently no suitable postoperative management for these localization problems. However, the discomfort felt by patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible to develop a rehabilitation protocol adapted to each patient. This project will focus on the evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory (auditory and visual) feedback, for bilateral CI adults.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years inclusive
* Use of the second CI for at least 1 year
* Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in Lyon
* Post-lingual deafness
* Average voice recognition over 80% with 2 Cochlear Implants
* Normal vision (with or without correction)
* Able to understand the experimental instructions
* Affiliated to a social security scheme

Exclusion Criteria:

* Oculomotor disorder
* Bilateral vestibular areflexia
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol

The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also called HU) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung disease, stroke, and blood infection.

The current observational trial, Follow-Up Study ((FUS) II includes enhanced neuropsychological, brain, cardiac, and pulmonary evaluations for this very well characterized cohort of subjects. Measures of spleen and renal function and markers of DNA damage will continue to be collected. Assessment of other target organs in sickle cell disease including pulmonary and cardiac function will be performed in addition to evaluation of developmental aspects of sickle cell disease (SCD) and potential HU toxicity.

Eligibility Criteria:
Inclusion Criteria:

* All subjects enrolled in the BABY HUG Follow-Up I Study who participated for at least 24 months are eligible for the Follow-Up Study II

Exclusion Criteria:

* Subjects that have received a Stem Cell Transplant are not eligible for enrollment
Assessing Respiratory Rate and Tidal Volume Delivery During Manual Ventilation

Excessive minute ventilation for patients who experience cardiac arrest may cause pulmonary injury and decrease the overall effectiveness of cardiopulmonary resuscitation (CPR). Although clinicians are trained with the correct technique for manual ventilation, evidence still shows that clinicians tend to deliver a higher respiratory rate than recommended during CPR. Little is known about tidal volume delivery during CPR; either the amount of volume give or even the impact of tidal volume on the effectiveness of CPR. There are many factors that may influence variations of tidal volumes and RR during CPR. These factors include distractions in the room (noise/cross talk), inability to assess tidal volume delivery, anxiety, and stress of the situation. This study will evaluate tidal volume and respiratory rate (RR) delivery during a simulated CPR situation. Participants will be asked to provide care for an intubated adult patient in cardiac arrest, which will include all components of advanced cardiac life support training.

This will be a cross-sectional study, conducted during regularly scheduled ACLS courses at Rush University Medical Center. Enrollment will be by random assignment as participants arrive for the ACLS course. Those that consent to the study will be informed that the investigator's study is to observe ACLS performance, but the exact parameters being measured will not be disclosed in an effort to mitigate any changes in behaviors.

During the course of the study, groups will be assigned sequentially, and the first group to participate will be termed as "Group 1". Within the group, each participant will be assigned a letter to identify the sequence of rotation with the skills. For example, the first participant in group 1 to perform manual ventilation will be assigned the study identity of "1A". The second person in the first group will be "1B", and so on.

During the ACLS megacode component of the ACLS training, each study participant will be given the opportunity to manually ventilate the simulated intubated adult patient, as per the normal rotation during a megacode. During the megacode, information will be collected via the NICO2 Respiratory Management System (Philips Respironics, Murrysville, Pennsylvania) that is attached to the endotracheal tube, which will be video recorded, as this system does not have function of data storage or downloaded. This is to assure each breath is captured so the study team can assure accuracy of data collection. None of the study participants will be video recorded.

At the completion of the study, each participant will be debriefed on their performance and informed of the true nature of the study; which is to evaluate respiratory rate and tidal volume delivery during manual ventilation to an intubated patient during an ACLS rescue attempt.

Eligibility Criteria:
Inclusion Criteria:

* 21 years old or older
* licensed clinician, regardless of medical profession

Exclusion Criteria:

* Full-time, non-licensed students that have no completed their formal training program at Rush University
Examination of Clinical and Laboratory Abnormalities in Patients With Defective DNA Repair: Xeroderma Pigmentosum, Cockayne Syndrome, or Trichothiodystrophy

Four rare genetic diseases, xeroderma pigmentosum (XP), Cockayne syndrome (CS), the XP/CS complex and trichothiodystrophy (TTD) have defective DNA excision repair although only XP has increased cancer susceptibility. We plan to perform careful clinical examination of selected patients with XP, XP/CS, CS, or TTD and follow their clinical course. We will obtain tissue (skin, blood, hair, buccal swabs) for laboratory examination of DNA repair and for genetic analysis. We hope to be able to correlate these laboratory abnormalities with the clinical features to better understand the mechanism of cancer prevention by DNA repair. Patients will be offered counseling and education for cancer control....

Three rare genetic diseases, xeroderma pigmentosum (XP), Cockayne syndrome (CS), and trichothiodystrophy (TTD) have defective DNA excision repair although only XP has increased cancer susceptibility. We plan to perform careful clinical examination of selected patients with XP, CS, TTD, or overlap syndromes to follow their clinical course. We will obtain tissue (skin, blood, hair, or buccal cells) for laboratory examination of DNA repair and for histologic, protein, biochemical, and genetic analysis. We hope to be able to correlate these laboratory abnormalities with the clinical features to better understand the mechanism of cancer prevention by DNA repair. Patients will be offered counseling and education for cancer control.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Subjects age 6 weeks and above:

  * with clinical and/or laboratory documentation of typical features or suggestive clinical features of XP, CS, TTD, or overlap syndromes or
  * that are first degree relatives or other family members of participants with XP, CS, TTD, or overlap syndromes
* Healthy volunteers of age 1 year and above (including NIH employees) willing to donate blood, skin, buccal cells, or hair.
* Patients or legally authorized representatives must provide informed consent.

EXCLUSION CRITERIA:

-Inability or unwillingness to provide tissue (skin, blood, buccal cells or hair) for laboratory studies.
BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension

The study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* PAH (pulmonary arterial hypertension)
* WHO functional class II-III

Exclusion Criteria:

* WHO functional class I or IV
* pregnancy
* known intolerance or allergy to beetroot
* treatment with Allopurinol
* treatment with Iloprost (inhaled)
* systolic bloodpressure \< 95 mmHg
* diabetes mellitus type 2
Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures

The present study is aimed to explore the treatment effect from the intake of probiotic Lactobacillus crispatus M247 in the improvement of clinical and psychological aspects in women undergoing homologous level 2 ART procedures.

The use of assisted reproductive technology (ART) has increased dramatically worldwide due to the continuous rise in infertility rates; for these reasons an increasing number of couples undertake the path of ART, even though this is difficult journey, with uncertain outcomes and possible medical risks, both physical and psychological.

In this study the investigators aim to explore the hypothesis that recreating a favorable vaginotype through the intake of the probiotic Lactobacillus crispatus M247 can have a positive effect in achieving pregnancy in cryopreserved cycles as well as a positive relationship between vaginal, endometrial (still unknown), gut and oral microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing homologous level 2 assisted reproductive technology (ART) procedures
* Cryopreserved oocytes
* D3 embryos
* D5 blastulae
* Age 18-45

Exclusion Criteria:

* Presence of submucous uterine myomas.
* Uterine malformations.
The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: a Prospective Blinded Multicentre Cohort Study

Microorganisms such as bacteria live naturally on and in the bodies and are of great importance for our health. In the female body, almost 10% of all microorganisms live in the reproductive organs and especially in the vagina. Healthy bacteria in the vagina can defend against harmful bacteria and infections. However, it occasionally happens that the balance between healthy and harmful bacteria is disturbed, and it is believed that this could potentially harm pregnancy. However, there is not much evidence to prove a connection between an imbalance in bacteria and having an unsuccessful pregnancy.

For this reason, the goal of our study is to determine if women with certain vaginal bacteria are more likely to experience pregnancy failures. If the investigators find this to be true, patients undergoing fertility treatment might be recommended regular tests in the future. If an imbalance in bacteria is found, doctors could provide treatment to restore a healthy vaginal environment, potentially improving the chances of a successful pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* ART patients undergoing the transfer of a euploid embryo

Exclusion Criteria:

* Patients with a body mass index (BMI) ≥35

  * Patients with uncorrected uterine malformations
  * Patients with a unicornuate uterus
  * Patients with a bicornuate uterus
  * Patients with any type of submucosal myoma
  * Patients with an intramural myoma if ≥4 cm
  * Patients with severe adenomyosis (\>50% of the uterine corpus affected as defined by the MUSA criteria \[19\])
  * Patients undergoing transfer of an embryo with a morphology score \<4BC (according to the Gardner \& Schoolcraft scoring system \[18\])
  * Patients undergoing transfer of a day-7 embryo
  * Patients who took antibiotics in the month prior to the embryo transfer (excluding antibiotics given following oocyte retrieval)
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate dependence treatment.


Eligibility Criteria:
Please contact site for information.
Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders

The goal of this observational study is to learn about heart rate variability and physical activity in inpatients with stress-related disorder. The main questions to answer are:

* whether heart rate variability shows the severity of certain symptoms.
* whether physical activity has an influence on heart rate variability and symptoms of stress-related disorder.

Participants will be asked to take part in 5 examinations during their up to 8-week inpatient treatment:

* Participate in an interview
* Measurement of heart rate variability, blood pressure and health of the arteries (pulse wave velocity)
* Tests of endurance, strength, balance and cognitive abilities
* Completion of two additional short questionnaires
* Wearing a 24-hour electrocardiogram
* Wearing a fitness watch and daily self-assessment of fatigue, mood and tension via an app on participant's mobile phone during their stay.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of an ICD-10 depressive episode (F32 or F33) and burnout (Z73) without psychotic symptoms
* German language skills
* mobile phone ownership
* age 18-35 years

Exclusion Criteria according to medical history:

* comorbid psychiatric disorder, including post-traumatic stress disorder as well as anxiety and panic disorder
* current treatment with antiarrhythmic drugs and tricyclic antidepressant medication
* factors precluding submaximal endurance test: history of cardiac diseases such as myocardial infarction, stroke and unstable heart failure within the previous six months impairing exercise testing and training, and heart failure (New York Heart Association functional class III and IV)
* factors severely affecting HRV parameters: type 1 \& 2 diabetes mellitus with clinically proven cardiovascular autonomic neuropathy, chronic obstructive pulmonary disease Global Initiative for Obstructive Lung Disease stage ≥ III, ongoing cancer treatment, moderate to severe chronic kidney disease (estimated Glomerular Filtration Rate stage 3a (G3a) or worse (≤ 45 ml/min)), current eating disorders such as anorexia nervosa and bulimia nervosa, excessive drug or alcohol abuse
* known pregnancy
* suicidal thoughts precluding informed consent