cyrilzakka/clinical-trials huggingface dataset:
Support Tool for Antibiotic Allergy DeLabeling

Antibiotic allergy labels (AAL) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of AAL, i.e., prevalence of 6%). They are associated with increased length of hospital stay, and use of second-line and broad-spectrum antibiotics. Allergy workups are able to invalidate the majority of these AAL but are time-consuming and require invasive skin and provocation testing. The investigators recently evaluated, for the first time in Europa, a strictly non-invasive delabeling protocol using a questionnaire, medical file search and contact with primary care health care workers in 200 adult internal medicine inpatients with a beta-lactam AAL. Up to half of the AAL could be removed or refined, demonstrating the potential of this strategy. In this project, they aim to assess the impact of using the non-invasive 'AAL-fact-check' tool in a multicenter study, on antibiotic selection, and clinical, antimicrobial, and economic endpoints, as compared with the standard of care (i.e., no AAL-fact-check tool).


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients
2. AAL for one or more beta-lactams

Exclusion Criteria:

1. Age younger than 18
2. Previous enrolment in this study
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill

The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.


Eligibility Criteria:
Inclusion Criteria:

* Providers involved with beta-lactam TDM for critically ill patients

Exclusion Criteria:

* None
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers

The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Willing and able to provide written informed consent
* Leg ulcer will be of size ranging between 10 cm2 - 40 cm2 with moderate or heavy exudate
* Leg ulcer will exhibit at least 2 of the 4 following clinical signs: pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour

Exclusion Criteria:

* Known skin sensitivity to any component of the products being tested
* Subjects who have had current local or systemic antibiotics and/or topical antimicrobials applied in the week prior to inclusion
* Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon)
* Any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
* Participated in a clinical study within the past 30 days
Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.

Per the NIH requirements the study team added the following language and also updated the registration to be an interventional study. The study will enroll adult patients with chronic constipation prior to appointment with a gastroenterologist that have not received anorectal function testing or treatment in the past. The study team will assess patients' constipation symptoms and then monitor whether providers order anorectal function testing or treatment as a primary outcome. Source data will be derived from the medical record to provide quality assurance. The sample size is necessary to evaluate this outcome measure while accounting for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results. The statistical analysis plan will be descriptive with reporting of our binary primary endpoints given the nature of this being a pilot study.

Eligibility Criteria:
Inclusion Criteria Participants:

* Participant has Chronic constipation as a main symptom
* Participant is able to participate in pelvic floor physical therapy

Exclusion Criteria Participants:

* Participant has taken narcotic pain medication in the past 30 days
* Participant has been scheduled for a test called an anorectal manometry in the past
* Participant has been scheduled to see a pelvic floor physical therapist in the past
* Participant is pregnant
Hypotensive Anesthesia With Sleeve Gastrectomy

to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end

to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 or more than 35 with comorbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 50
* patients with BMI less than 35
* patient with previous upper abdominal surgery either for obesity or other diseases
* patients with GERD
Microbiota as Potential Target for Food Allergy

Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.


Eligibility Criteria:
Inclusion Criteria:

* children with cow's milk allergy
* age 6-12 months

Exclusion Criteria:

* concomitant chronic systemic diseases
* congenital cardiac defects
* active tuberculosis
* autoimmune diseases
* immunodeficiency
* chronic inflammatory bowel diseases
* celiac disease, cystic fibrosis
* metabolic diseases
* malignancy
* chronic pulmonary diseases
* malformations of the gastrointestinal tract
* suspected eosinophilic esophagitis or eosinophilic enterocolitis
* suspected food-protein-induced enterocolitis syndrome.
Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

The purpose of this study is to determine if kinesiotaping for edema management will decrease post-operative edema in patients with bilateral total knee arthroplasty. The leg receiving kinesiotaping during inpatient rehabilitation may have decreased edema and pain and improved movement and function when compared to the leg not receiving kinesiotape.

After being informed about the study and potential risk, all patients undergoing inpatient rehabilitation after bilateral total knee arthroplasty will have Kinesio(R)Tape applied to one randomly selected leg while the other leg serves as a control. Measurement of bilateral leg circumference, knee range of motion, numerical rating scale for pain, and selected questions from the Knee Injury and Osteoarthritis Outcome Score will occur at regular intervals throughout the rehabilitation stay. Patients will receive standard rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;
* 50-85 years of age;
* able to read and understand English or a hospital-provided translator when consenting for the study;
* free from contraindications for kinesiotaping (see below); and,
* able to tolerate an active rehabilitation program.

Exclusion Criteria:

* stage III or IV heart failure, stage III or IV renal failure;
* fragile, very hairy or sensitive skin;
* anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites
* active skin rashes or infections or skin lesions in the lower extremity;
* prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives;
* prior history of lower extremity lymphedema;3
* prior history of lower extremity venous or arterial disease;
* post-operative complications in the surgical sites;4
* partial joint arthroplasty or revision arthroplasty of one or both knees;1,5
* inability to give informed consent offered in English or through a hospital-provided translator
* age less than 50 years or over 85 years;
* inability to tolerate an active rehabilitation program.
The Effect of Intervention With Probiotic K56 on Body Fat Reduction in Obese Subjects

The aim of the present study was to investigate the effect of intervention with Lactobacillus paracasei K56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity.

Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.

In this randomised,double blind ,placebo controlled study, the participants were randomly assigned to probiotic K56 group or placebo group to evaluate the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing probiotic or placebo capsules.

Eligibility Criteria:
Inclusion Criteria:

* Obesity : BMI\>=30kg/m2,or percent body fat(PBF) \>=25% for male, \>=30% for female.

（Note: If PBF was eligible, it was recommended that 26 ≤ BMI ≤ 40）

* Age: 40 - 65 years old adults
* Who has the conditions to preserve the test samples at low temperature throughout the whole process

Exclusion Criteria:

* Patients with severe chronic diseases（heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental illness and organ surgery history, etc.) and complications;
* Patients with severe allergy and immunodeficiency;
* Patients with a clear history of gastrointestinal diseases (ulcer, irritable bowel syndrome, etc.);
* History of intervention with fat-reducing drugs or health products in the past 2 months
* Take weight control measures (diet, exercise, etc.) within the past month
* Participation in other clinical trials within the past 3 months
* who have used antibiotics in the past 2weeks ;
* Those who cannot guarantee to maintain their current lifestyle during the trial period
* Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy
Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy

To analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy


Eligibility Criteria:
Inclusion Criteria:

* age between 4 and 14 years
* diagnosis of motor and cognitive disability
* have prescribed physiotherapy treatment at school
* acquisition of autonomous sitting
* sign the consent informed

Exclusion Criteria:

* presentation of an allergic reaction to tape
* presentation of wounds in the area of application of the tape
* having received botulinum toxin treatment in the last 6 months
Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of T2DM prior to informed consent
2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
3. Stable metformin therapy: daily dose \>=1500 mg/day or maximum tolerated dose
4. HbA1c \>=7.5% and \<=10% at screening

Exclusion criteria:

1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in
2. Any contraindications to metformin according to the local label
3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent
DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TxA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TxA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TxA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TxA is used directly on the tissues (topically) for other type of surgeries (joints), TxA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TxA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (CABG), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy
3. Provide written informed consent

Exclusion Criteria:

1. Allergy to tranexamic acid
2. Undergoing minimally invasive surgery
3. Fulfill any of the following transfusion risk factors (A-D):

   A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active)
4. History of previous cardiac surgery
5. Estimated glomerular filtration rate \<30 mL/min (CKD-EPI equation) or on dialysis
6. Pre-operative hemoglobin \> 170 g/L or \<110 g/L
7. Pre-operative thrombocytopenia (\<50,000 platelets per µL)
8. Expected circulatory arrest
9. Pregnancy or breast feeding
10. Previously enrolled in the DEPOSITION trial
11. Refusal of blood products
12. Pericardiectomy
Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days

This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.

The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is able to read, understand and sign informed consent.
2. Provision of signed and dated informed consent and HIPAA authorization .
3. Willingness to comply with study procedures and availabilty for duration of study.
4. Aged 18-85, male or female
5. Minimum of 5 central corneal superficial punctate keratitis spots.
6. Normal eyelid anatomy
7. highly effective contraception for at least 1 month prior to screening and agreement to use effective contraception during study participation and for an additional 4 weeks after study drug discontinuation.
8. Postmenopausal or surgical sterilization.

   -

Exclusion Criteria:

1. Known hypersensitivity or contraindication to investigational product.
2. Contact lens use within one month prior to screening
3. Unwilling to discontinue contact lens.
4. pregnancy or lactation.
5. topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.
6. Ocular surgery or eyelid surgery within 6 months prior to screening
7. Subjects can be on the following medications if they have been on a stable dose for 12 weeks: loteprednol, tetracycline, omega 3, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressives including oral steroids, non-steroidals, antihistamines, mast cell stabilizers, punctal plugs, corticotropin repository or glaucoma medications.
8. abstain from eyelast growth products containing prostaglandin
9. Must not have had penetrating intraocular surgery, refractive surgery, cornea transplant, eyelid surgery within 6 months prior to Visit 1
10. Febrile illness within 1 week
11. Treatment with another investigational drug or intervention within one month
12. History of herpetic keratitis.
13. Serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study study assessments or limit compliance.
14. Use of new prescription eyedrop within 90 days of screening.
15. Change in systemic medication within 90 days of screening
16. Anticipated relocation or extensive travel during study period. -
Different Level of ECSWT in Post Mastectomy Lymphedema

to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)

The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

- Criteria of selecting the patients from hospital included the following;

1. Their ages ranged from 30 to 50 years.
2. All patients were examined carefully by physician before the study procedure.
3. All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema.
4. They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention.
5. Only ambulant subjects without any aides will be selected.
6. The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ).
7. All patients will be medically stable.
8. Each patient will sign a consent form which in that insures her eligibility in the study.
9. All patients were treated by the same doctor and physiotherapist.

Exclusion Criteria:

* The subjects had been excluded from the study if they met one of the following criteria;

  1. The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases.
  2. Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded.
  3. The patients had neurological or orthopedic problems, and diabetes.
  4. Patients with primary lymphedema.
  5. Cardiopulmonary disease which decrease the patient activites.
Pre-operative Characteristics for Prediction of Supraglottic Airway Failure Using Machine Learning (ERICA)

Supraglottic airway devices (SGA) are a safe and well-established technique for airway management. Nowadays, up to 60% of general anaesthetics performed in European countries use SGA. In 0.2-4.7% SGA fail and require conversion to tracheal tubes.

The ERICA study will use artificial intelligence methods to develop a model that can predict the risk of an unplanned SGA conversion based on pre-operative characteristics available during the premedication visit.

An intraoperative change of procedure not only leads to time delays but also time delays, but also involves measures that are stressful for the patient, such as deepening the anaesthesia and manipulating the airway again.

Therefore, the objective of ERICA is to develop a machine learning algorithm based on preoperative information 1) that can accurately predict the risk of an unplanned SGA conversion and 2) identifies characteristics leading to conversion from SGA to tracheal tube.

I. Developing the model

• The final dataset will be split in a training, testing, and validation cohort. Five models will be created to predict intraoperative conversion from SGA to tracheal tube including generalized linear models (GLM), deep learning, distributed random forest (DRF), xgboost and gradient boosting machine (GBM). Then, a stacked ensemble model will be constructed through combination of the five models. Finally, the best artificial intelligence model will be chosen.

II. Identify characteristics leading to the airway conversion and categorisation.

* Intraoperative changes of the patient's position can alter the risk of conversion, therefore operations with positional changes should be considered
* Identify patient- and procedure-dependent characteristics that lead to conversion from SGA to tracheal tube and their importance.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) receiving general anaesthesia for non-cardiac surgery with a supraglottic airway device

Exclusion Criteria:

* None
Quality of Nursing Care During The Covid-19 Pandemic

Enabling school-age children to evaluate the care they receive provides feedback on the quality of care by determining children's satisfaction with care, and gives important feedback on the quantity and quality of care. Evaluation of nursing care, emotions and behaviors from the perspective of children during the Covid-19 pandemic process will guide the improvement of the quality of care. As a result of the literature review on this subject, no research has been found, and it is thought that this research will contribute to the field. This research was conducted to evaluate nursing care and emotions from the perspective of hospitalized children during the Covid-19 pandemic process.


Eligibility Criteria:
Inclusion Criteria:

* The study included volunteer children who were hospitalized for at least 3 days in the - -- -pediatric clinic,
* whose native language was Turkish,
* between the ages of 8-13,
* who did not have any visual, auditory or mental problems, and whose parents gave consent for the study.

Exclusion Criteria:

* who fall outside the inclusion criteria
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso

The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.


Eligibility Criteria:
Inclusion Criteria:

* 0.5-5 year (6-59 months) old children
* uncomplicated malaria caused by P. falciparum
* asexual parasites ≥ 2000/µ and ≤ 200000/µ
* axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
* Burkinabe nationality
* informed consent

Exclusion Criteria:

* complicated or severe malaria
* any apparent significant disease
* anaemia (haematocrit \< 21%)
* treated in the same trial before
* modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine