cyrilzakka/clinical-trials huggingface dataset:
The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children

The purpose of this current study is to compare changes of the intracuff pressure in the newly designed LMA with the older design LMA after insertion of an esophagogastroduodenoscopy (EGD) probe in pediatric patients and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Patients who weigh more than 30 kg
* Patients undergoing an EGD
* Patients getting an LMA

Exclusion Criteria:

* Patients who weigh less than 30 kg
* Use of an EGD probe with an OD greater than 14 mm
* Decision not to use an LMA for the procedure
* Tracheomalacia, bronchomalacia, or any other airway issues
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).

Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.

Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.

Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilled Rome III diagnostic criteria for IBS
* Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
* Able to read and speak Danish
* Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool

Exclusion Criteria:

* Other chronic gastrointestinal disease
* Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
* Positive screening for HIV, Hepatitis B or HCV antibody
* Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
* Psychiatric disorder
* Fecal calprotectin ≥ 50 mg/kg
* Abuse of alcohol or drugs
* Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
* Abnormal screening biochemistry
* Abnormal colonoscopy findings
* Pregnant, planned pregnancy or breastfeeding females
* Ingestion of probiotics or antibiotics \< 8 weeks before the inclusion

Inclusion criteria for donors

* Age between 18-45 years
* Past and current healthy
* Normal weight (BMI between 18,5-24,9 kg/m2)
* Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
* No medication consumption

Exclusion criteria for donors

* Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
* Positive stool sample for C. difficile toxin, parasites or other pathogens
* Antibiotic treatment in the past 6 months
* Abuse of alcohol or drugs
* Smoking
* Tattoo or body piercing within the last 6 months
* Allergy, asthma or eczema
* Family history of gastrointestinal diseases
* Participation in high-risk sexual behaviors
* Born by Caesarean section
Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy

This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy

Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (\<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Women, aged ≥ 18 years
* Invasive HER2+ (HR+/-) or TN breast cancer
* Primary tumor (T), clinical stage T1-3
* Neoadjuvant systemic therapy (NST), at least 3 cycles
* Tumor stage assessed with breast MRI before start NST
* Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
* MRI after or during NST shows radiologic complete response
* Written and signed informed consent

Exclusion Criteria:

* Primary tumor (T) clinical stage T4
* Patients without ultrasound or FDG-PET/CT pre-NST
* History of breast cancer ipsilateral breast
* Synchronous contralateral breast cancer
* Synchronous M1 disease
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

The primary objective of this study is to evaluate the need for and time to small bowel transplantation or liver transplantation. This will be calculated as both the age at time of primary transplant as well as the length of time from initial evaluation to transplant.Secondary objectives are to determine if there are improvements in clinical measures associated with established parenteral nutrition- associated liver disease (PNALD). These will be determined by measurement of total and direct bilirubin levels, platelet count, serum albumin, and changes in both length and weight growth curves.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:
* Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days
* Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment
* Signed patient informed consent

Exclusion Criteria:

* Parent or guardian or child unwilling to provide consent or assent
* Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program
* Allergies or clinical conditions precluding safe use of Omegaven™
Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study

Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event.

The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

This study will be designed as followed : Patients will be randomized in 2 groups :"PREOXYFLOW" or "STANDARD FACE MASK".

Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction

Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years regardless of the gender
* Acute hypoxemic respiratory failure defined as :

Respiratory rate \> 30/mn AND Hypoxemia with SpO2 \<90% with oxygen supply \> FiO2 0,5 AND PaO2/FiO2 \<300 mmHg

Exclusion Criteria:

* Contraindication to oro-tracheal intubation
* Intubation without anesthetic delivery
* Intubation during cardiac arrest
* Asphyxia with immediate intubation needed
* Nasopharyngeal obstacle with contraindication to use Optiflow device
* Patients with a documented Cormack IV exposition before inclusion
* Protected adult
* Pregnancy
* Lack of consent
* Patient already enrolled in an other randomized study.
Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection

The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.

The analysis will include:

* study the expression levels of molecules known to mediated viral infection, like the Angiotensin converting enzyme 2 (ACE2) and genetic variants in these genes, which could be related to susceptibility to the viral infection and/or to the severity of the clinical course of the disease
* compare the frequency of genetic variants potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU
* germline DNA analysis to search for genetic factors predisposing or protecting against severe pulmonary affection in COVID-19 infected participants. To this aim DNA will be analyzed by a GWAS (Genome Wide Association Study) approach by using the GSA Illumina chip. The obtained data will also be used to try to develop a polygenic risk score to stratify individuals with a particularly high or low risk for severe disease course
* explore the contribution of rare variants by studying the exome
* sepsis and ARDS biomarkers developed at ICH (e.g. PTX3, sIL-1R2, MSF) analysis to address their prognostic potential in Covid-19 patients
* PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome
* microbiota analysis of residual BAL and pharyngeal swab to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection
* plasma and saliva/sputum test for anti-SARS-Cov-2 antibodies (IgM, IgG, IgE and IgA) and for microbiota analysis

Eligibility Criteria:
Inclusion Criteria:

* 1. Individuals aged ≥ 18 years;

Exclusion Criteria:

* 1. Lack of informed consent according to local procedure per critically ill patients.
COSMED K5 Validation and Reliability Study

To determine the validity of the K5 metabolic system breath-by-breath analysis setting during a high intensity treadmill running protocol compared to the criterion ParvoMedics TrueOne® 2400 automated metabolic gas analysis system.

To determine the test-retest reliability of the K5 metabolic system breath-by-breath analyzer during a high intensity treadmill protocol (Bruce Protocol).


Eligibility Criteria:
Inclusion Criteria:

* 20-29 years of age

Exclusion Criteria:

* Pregnancy
* Children
* Inmates
* Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation
* Contraindications to Symptom-limited Maximal Exercise Testing
* Metabolic disease
* Pacemakers/Implantable devices
* Supplemental Oxygen use
* Diagnosis of severe arterial hypertension
* Uncontrolled asthma
Quit and Win Contests to Improve Smoking Cessation Among College Students

Standard Quit and Win contests, in which smokers typically quit for one month in return for the opportunity to win prizes, are simple and easy to implement and may be cost-effective in encouraging smokers to quit. By extending contest length and enhancing counseling content, Quit and Win contests may be more effective at encouraging smoking abstinence.

This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win contests to enhance smoking abstinence at college campuses.

Participants will be randomized to 1 of 4 treatment groups with varying counseling treatments and contest lengths. All participants receive a 2 week supply of nicotine replacement therapy (NRT) and weekly support emails. Follow-up assessment surveys occur at 1, 3, 4 and 6 months post enrollment.

Participants who have completed the follow-up assessment surveys and self-reported that they are tobacco-free will be asked to provide a urine sample in order to verify abstinence.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled full or part-time at one of the participating campuses
* Smoke at least 10 days per month
* Intending to be in school for the entire academic year (i.e., next 2 semesters)
* Willing to provide a baseline urine sample to verify smoking status
* Able to read English
* Access to working telephone for phone-based counseling and surveys
* Access to a computer with internet access
* Provide written informed consent

Exclusion Criteria:

* Prior to concurrent enrollment in this study through a different college campus or in a different academic year
* those who have used a cessation aid within the last 7 days
* pregnant or planning to become pregnant in next 3 months
Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections

The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint

The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint all patients were screened by serum samples to detect IgM / IgG to Chlamydia trachomatis (DRG Chlamydia Trachomatis IgM / IgG Enzyme immunoassay) and by high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR- (from +ve samples to chlamydial IgM / IgG).

Eligibility Criteria:
Inclusion Criteria:

* The Study group included Women with recent unexplained early miscarriage (pregnancy duration 12 weeks or less and miscarriage within 4 weeks)
* The control group included Women with any other gynecological complaint or in need of family planning

Exclusion Criteria:

* Miscarriage of Pregnancy duration more than 12 ws Documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome, endocrine factors....etc
* Recent antibiotic, antifungal or antiprotozoal treatment
The TRIMAXX Coronary Stent Trial

The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.

The TriMaxx study is a prospective, multicenter, non-randomized, single-arm trial intended to demonstrate the safety and feasibility of the TriMaxx Cornary Stent System. The study will enroll 100 subjects with de novo native coronary artery lesions who meet the eligibility criteria and agree to participate in the study. Subjects will be enrolled in a sequential manner. The safety and feasibility of the TRIMAXX stent will be evaluated by comparing the MACE rate that is observed 30 days post-procedure to the MACE rate for commercially available non-drug eluting stents. Secoandry evaluations will include analysis of clinical and angiographic parameters at 6 months. All subjects will undergo assessments at 30 days and at 6 months. Additionally, all subjects will undergo a follow-up angiogram at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for catheter based treatment
* Single coronary lesion requiring treatment
* Lesion is accessible with stent device
* Completes informed consent for participation
* Stable condition (no symptoms of heart attack within 72 hours prior to treatment)

Exclusion Criteria:

* Normal lab values
* Previous treatment in the affected artery
Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: the OPUS Anesthesia Pilot Trial

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Adults \>/= 18 years.
2. Having elective major non-cardiac surgery (i.e., planned duration \>/= 1.5 hours and anticipated \>/= 1 night hospital stay).
3. Requiring general anesthesia.
4. Able to complete baseline quality of recovery assessment.

Exclusion Criteria:

1. Individuals with known contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe renal or hepatic failure, bradycardia or hypotension), as per routine assessment.
2. Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
3. Pregnant women.
4. Planned use of regional analgesia (i.e., epidural, peripheral nerve block, trunk nerve block) in conjunction with general anesthesia. Local anesthetics such as lidocaine are administered as part of regional analgesia technique. Combination with intravenous lidocaine is contraindicated to avoid exceeding therapeutic concentration.
5. Planned postoperative intubation after PACU discharge.
6. No fixed address.
Heavy Menstrual Bleeding and Iron Deficiency Anemia

In the present study, we test the ability of AMSS as a simple tool to identify women with HMB who have ID/ IDA. We will compare the AMSS score to patients' hemoglobin and serum ferritin in women with self-reported HMB and women with normal menstrual flow.

Anemia remains a critical health burden in low- and middle-income countries (LMICs) and a paradigm shift is needed to effectively reduce the prevalence in women. The reproductive years place women at high risk of anemia in general, and iron deficiency anemia (IDA) in particular, largely because of menstrual and delivery -associated blood loss, as the lost iron is often not adequately replenished from dietary sources. Iron deficiency, even without anemia, has profound adverse effects on multiple cellular and metabolic parameters and frequently manifests with impaired cognitive and physical function. In Africa and Eastern Mediterranean regions, around 39% of non-pregnant women and 40-45% of pregnant women have anemia as estimated by The World Health Organization (WHO). Maternal anemia is a risk factor for preterm labor and both maternal and neonatal morbidity and mortality. Although data is limited, 5-28% of women in LMICs experience abnormal uterine bleeding (AUB) yet the importance of menstrual blood loss as an indicator of and a risk factor for anemia is frequently ignored in anemia control and prevention strategies. The condition is further complicated by the fact that both women and their physicians tend to normalize menstrual symptoms. To enable development of comprehensive interventions to address IDA among women in our locality, it is critical to characterize heavy menstrual bleeding (HMB) and its relationship with IDA among women and determine ways to use these data to direct women at risk for IDA to appropriate healthcare services for evaluation and treatment.

For women with HMB, early diagnosis and treatment of anemia is important to prevent its negative health consequences. However, in low resource settings, laboratory facilities are not always available. In addition, laboratory tests may be expensive limiting their use in such circumstances. For this reason, a cheap, simple to use tool to identify women at high risk of anemia who require further evaluation and treatment is needed.

The Aberdeen Menorrhagia Severity Scale (AMSS) is a multi-dimensional scale. It measures quality of life in women with HMB in addition to menstrual bleeding characteristics. AMSS consists of 13 questions. with a 4-point answer to each question. Maximum score is 47, which is converted to a percentage. The lower the scale is associated with better quality of life. The AMSS has been validated against the SF-36, which is a generic scale for measurement of quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age women, above age of 18 years old.

Exclusion Criteria:

* women with amenorrhea, postmenopausal women, current or past (in last 6 months) users of hormonal contraceptives, women who have delivered in the past year, or breast fed in past 6 months are all excluded from the study
Thiamine Supplementation in High Risk Cardiac Surgery Patients

This pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia in high risk cardiac surgery patients

Thiamine has a pivotal role and is an essential cofactor for pyruvate dehydrogenase activity. Widely known wet beri-beri is developed due to thiamine deficiency and characterized by vasodilatory shock and despaired oxygen extraction leading to kidney, heart and central nervous system dysfunction. Thiamine deficiency is often underestimated and even in primary absence of vitamin B1 deficiency, high-consumptive state of many critical illness and cardiac surgery itself can lead to its lack. Reported that in patients on chronic dialysis and patients with AKI requiring RRT thiamine deficiency is a usual finding. In cross-sectional observational study it has been shown that up to 33% of patients with a diagnosis of congestive heart failure (CHF) had thiamine deficiency due to chronic loop diuretic use. Also reported that 96% of patients (21 of 23) with heart failure receiving loop diuretic therapy (daily dose: 80-240 mg furosemide) developed thiamine deficiency. In prospective observational trial it has been shown that plasma thiamine levels were decreased after CABG surgery.

In a secondary analysis of a randomized, double-blind, placebo-controlled trial conducted in septic patients, thiamine supplementation showed highly-promising renal protective effect. Need for RRT was 8 patients (21%) in placebo group and 1 patient (3%) in thiamine group (p=0.04).

On the other hand it was unable to show any benefit of thiamine supplementation in patients undergoing CABG surgery. Although, postoperative oxygen consumption was significantly increased among patients receiving thiamine.

Nevertheless, existing evidence suggests that thiamine supplementation might be an attractive strategy in counteracting organ dysfunction and thus morbidity and mortality in high-risk cardiac surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Valve surgery + CABG that required cardiac surgery with CPB
* Aged 18 years or older
* Signed informed consent

Exclusion Criteria:

* Emergency surgery
* Chronic kidney disease of G4-G5 categories according to KDIGO criteria (at least one of the following present for \> 3 months: glomerular filtration rate ≤ 29 ml/min/1.73 m2, history of kidney transplantation)
* Known allergy to thiamine
* Pregnancy
* Current enrollment into another RCT (in the last 30 days)
* Previous enrollment and randomisation into the APPLY trial
* Administration of thiamine in the previous 30 day