cyrilzakka/clinical-trials huggingface dataset:
Triaging and Referring in Adjacent General and Emergency Departments

Introduction: Patients who might also go to the general practitioner (GP) frequently consult emergency departments (ED). This leads to additional costs for both government and patient and a high workload for emergency physicians in Flanders. The Belgian government wants to address this problem by improved collaboration between EDs and general practice cooperatives (GPCs).

Intervention: Patients presenting at the ED during out-of-hours (OOH) will be triaged and allocated to the most appropriate service. For this purpose the Manchester Triage System (MTS) which is commonly used in Flemish hospitals, will be extended (eMTS). By doing so a trained nurse will be able to diverge suitable patients towards the GPC.

Methodology: The investigators will conduct a cluster randomised controlled trial in which eligible ED patients will be diverged to the GPC using the eMTS. The investigators will collect data using the iCAREdata database. The investigators will study the use of the eMTS, the effectiveness and effects of triage, work load changes, epidemiology at both departments, patient safety, health insurance (HIS) and patient expenditures. Furthermore, facilitators and barriers will be studied and an incident analysis of problem cases will be performed.

Outcome: The primary outcome is the proportion of patients who enter the ED and are handled by the GP after triage. Secondary outcome measurements are related to safety: referral rate to the ED by the GP, proportion of patients not following the triage advice and file review for selected patients.


Eligibility Criteria:
Inclusion Criteria:

* availability of a Belgian citizen national insurance number

Exclusion Criteria:

* Patients arriving at the ED by an ambulance with a doctor or nurse
* Patients all ready admitted to an other hospital department
PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.

This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.

The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours.

A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned.


Eligibility Criteria:
Inclusion Criteria:

Newborns at 36 weeks gestation or more, with HIE treated with therapeutic hypothermia will be prospectively included.

Exclusion Criteria:

* Lack of parental consent
* Congenital anomalies that make hypothermia treatment not indicated
* Coagulopathy with active bleeding
A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese NICU: a Pilot Study

To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality improvement program to increase breast milk feeding, and to evaluate its impact.

The benefits of breast milk are well recognized for providing health benefits in early infancy and extending into adulthood, and breast milk feeding is promoted by numerous professional organizations. However, for various reasons, in neonatal intensive care unit in China, most infants are separated from their parents and are fed infant formula exclusively. To address this problem, the investigators propose to carry out a pilot study to assess the prevalence of breast milk feeding in a NICU of a tertiary teaching hospital in China, and then to introduce an intervention program to increase the prevalence of breast milk feeding and to evaluate the impact of this program.

The intervention would include building a nutrition team in the NICU, training of a lactation coordinator and nursing staff by a team from Mount Sinai Hospital, providing parents with education on breast milk feeding, providing access to breast pumps through a lend/lease program and providing a breast pumping room for parents. The investigators will collect data on breast milk feeding, including prevalence and reasons for not breast milk feeding during both the pre-intervention and intervention period. The investigators will also assess the enrolled infants' weight gain from admission to discharge, incidence of nosocomial infection and mortality, and average length of stay in the NICU, to assess the efficacy of the breast milk feeding intervention.

This trial has the potential to dramatically change feeding of infants in Chinese NICUs from exclusive infant formula to breast milk, with potential impacts on nosocomial infection, growth, development and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

1. all very low birth weight(birthweight ≤ 1500g)infants admitted to the NICU of Children's Hospital of Fudan University
2. informed consent is given

Exclusion Criteria:

1. Presence of breast milk feeding contraindications
2. Severe illness with contraindications for feeding
Risk Assessment of Proximal Contact Loss Between Implant-supported Prostheses and Adjacent Teeth.

In this study, we collected and analysed the review results of 100 patients over 18 years of age who received implant fixed restorations in the Department of Stomatology of the First Hospital of Nanjing, China. The aim was to investigate the incidence of loss of contact between implant restorations and adjacent teeth and its influencing factors. Our findings may provide better insights for treatment planning and prevention of PCL.

Food impaction is a common complication after implant-supported restorations. Several studies have reported that more than 40%-66.9% of patients feel food impaction between the implant restoration and adjacent natural teeth. The most common cause of food impaction after implant restoration is the proximal contact loss(PCL), which has been reported to occur in 34% to 65% of cases. The location of PCL creates discomfort and leads to gingival inflammation and even peri-implant bone resorption, which ultimately leads to loosening of the implant. In our long-term clinical observation, not all final restorations suffer from PCL. The occurrence of PCL may be related to a number of factors such as age, gender, functional time, and so on. However, the literature addressing this issue is still limited. In this study, we collected and analysed the review results of selected patients who underwent implant-supported restorations in the First Hospital of Nanjing, China, to investigate the incidence of PCL between the implant restorations and the adjacent teeth adjacent , and the factors influencing it. Our findings may provide better insights for treatment planning and prevention of PCL.

Eligibility Criteria:
Inclusion Criteria:

* (1) Patients over the age of 18, can fully understand the nature of the proposed and be able to sign a consent form.
* (2) patients who underwent dental implant surgery and delivered prostheses for more than 3 months in Nanjing First Hospital.

Exclusion Criteria:

* (1) The implant site or adjacent teeth were severely injured and the adjacent teeth were extracted;
* (2) the same quadrant orthodontic or splint treatment;
* (3) the prostheses have been removed due to failure or need further treatment;
* (4) implant-supported prostheses in both mesial and distal sites;
* (5) the adjacent teeth were directly or indirectly fixed with the implant-supported prosthesis;
* (6) patients with missing clinical records of PD, PCR and BOP.
* (7) The prosthetic prosthesis with implant-supported prosthesis was delivered for less than 3 months in Nanjing First Hospital.
Lung Microbiota and VAP Development (PULMIVAP)

Ventilator-associated pneumonia (VAP) refers to a lower respiratory tract nosocomial infection acquired \>48h after being intubated in Intensive Care Units. Pathogenesis of VAP is mechanical and associated with microaspiration and leakage of oropharyngeal secretions around the endotracheal tube. A novel approach to VAP will attempt to explore how the abrupt ecological order of acute infection (high bacterial biomass, low community diversity) emerges from the dynamic homeostasis of a pre-existing ecosystem in which lung microbiota and local immunity interaction play their essential role.

Therefore, the investigators aim to explore if oral and lung microbiota modifications with local immunity changes, contribute in the pathogenesis of VAP in patients intubated for non-pulmonary reasons. Early changes in the host microbiota with the innate immunity system impairs tissue homeostasis and may represent a new distinct condition and a potential tool for early diagnosis and prevention of VAP.

Several factors are involved in the pathogenesis of VAP: the presence of endotracheal tube, the creation of bacterial biofilms around the device, host characteristics (comorbidities, surgery, antibiotic exposure) and, finally, immunological factors (including modulation of cytokine expression). In this study, patients mechanically ventilated for non-pulmonary reasons, will be followed up to 15 days of ventilation, estubation or death (whichever comes first). For microbiota analysis, all patients who develop VAP in the first 15 days of MV will be selected and matched (1:1; by center, gender, age (+/- 10 years), reason for intubation, duration of intubation), with a patient who do not developed VAP during MV. The optimal matching algorithm will be used to identify the control group that minimizes the total intra-pair dissimilarity.

The investigators plan to enroll about 700 MV patients for non-pulmonary conditions in order to describe VAP and non-VAP patients' characteristics identify. The investigators estimate that at least 70 patients will develop VAP in the first 15 days of MV. Microbiota and immunological analysis will be longitudinally performed on tracheal aspirate samples and oro-pharyngeal swab. The investigators will performe microbiota analyses on tracheal aspirate and oropharyngeal swab according to the following time schedule:

* VAP patient, 3 times: intubation (T0), the 24h before VAP development (T pre-VAP) and at VAP development (T-VAP).
* non-VAP patient, 2 times: intubation (T0) and a second sample, selected at the time point (day), corresponding to T-VAP of his/her matched VAP-patient (T no-VAP).

The investigators will perform immunological analysis on tracheal aspirate for all patients at intubation and at T-VAP or T no-VAP time.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Patients ventilated for reasons other than pulmonary failure with an expected need for MV longer than 48 hours

Exclusion Criteria:

* Admission in ICU with a pneumonia
* Clinical Pulmonary Infectious Score (CPIS) \> 6
* Antibiotic therapy \> 3 days prior to the start of MV
A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.


Eligibility Criteria:
Inclusion Criteria:

W8M-MC-LAA1

* Are males and females who agree to abide by the reproductive and contraceptive requirements

W8M-MC-CWMM:

* Have a BMI ≥27 kg/m²
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

W8M-MC-LAA1

* Have any prior diagnosis of diabetes mellitus except gestational diabetes.
* Have any of the following cardiovascular conditions within 6 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure (CHF).
* Have a history of acute or chronic pancreatitis.
* Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.

W8M-MC-CWMM

* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have a lifetime history of suicide attempts.
Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)

This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.

This is an open-label, safety and efficacy, escalating dose, single arm study on 9 adult subjects (3 cohorts) and 3+3 design will be used. HLA typed patients and potential blood-related donors will be screened for comorbidities. Suitably matched or haploidentical family donors will be selected according to protocol specified criteria and institutional guidelines of participating site.

Eligibility Criteria:
Inclusion Criteria:

1. History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
2. Relapsed or refractory AML

   1. AML relapse after intensive chemotherapy OR
   2. AML relapse after allogeneic HCT OR
   3. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR
   4. No response to at least 4 cycles of low intensity therapy
   5. AML refractory to 2 cycles of induction chemotherapy
3. Presence of \> 5% of blasts in bone marrow or peripheral blood smear
4. Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
5. Considered suitable for lymphodepleting chemotherapy
6. Age 18 years up to the age of 70 (≤ 70)
7. Life expectancy of at least 3 months
8. Karnofsky performance status ≥ 50%
9. Available related HLA-haploidentical or HLA-matched donor
10. Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.
11. Patient able to understand and sign written informed consent

Exclusion Criteria:

1. Uncontrolled infections
2. Renal insufficiency: creatinine \> 180 μmol/L or on dialysis
3. Heart failure: EF \< 40%
4. Respiratory insufficiency: oxygen therapy required at inclusion in the study
5. Significant liver impairment: bilirubin \> 50 μmol/L, AST or ALT \> 4 times normal upper limit
6. Treatment with bisphosphonates (2 months before start)
7. Active autoimmune disease or GvHD
8. Pregnant or breastfeeding
9. Patient of fertile age not using two-barrier method of birth control.
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years and ≤90 years of age.
2. Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
3. Sepsis due to infection in at least one of the below organs:

   3.1. Community-Acquired Pneumonia (CAP). 3.2. Urinary tract infection 3.3. Acute cholecystitis diagnosed by Tokyo criteria 3.4. Acute cholangitis diagnosed by Tokyo criteria 3.5. Other intra-abdominal infections (IAI) 3.6. Skin or soft tissue infection
4. Adequate source control

Exclusion Criteria:

1. Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
2. On chronic dialysis.
3. Patients with acute pancreatitis
4. Moribund patients
5. Weight \<50 kg or \>120 kg or BMI \>40 kg/m\^2.
6. SOFA score ≥14 at screening.
7. Patients with nosocomial infection.
8. A known malignancy.
9. Patients with end-stage disease (unrelated to sepsis)
10. Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV, HIV or other chronic infections.
11. Chronic respiratory disease.
12. Known active upper GI tract ulceration or hepatic dysfunction.
13. Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction.
14. Known immunocompromised state or medications known to be immunosuppressive.
15. Organ allograft or previous history of stem cell transplantation.
Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.

The purpose of this study is to determine the importance of uptake drug transporters in the drug disposition of warfarin. We predict that the elimination of warfarin will be decreased when co-dosed with an inhibitor of uptake drug transporters.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-60 years of age;
* Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations;
* BMI between 18.5 - 30 kg/m2;
* Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen);
* Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use;
* Be able to provide written informed consent and comply with requirements of the study;
* Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
* Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
* Avoidance of contact sports and/or other activities with significant risk of trauma injury for 7 days after each study day.
* Fast from food and beverages at least 8 hours prior to medication dosing;
* Be able to read, speak and understand English

Exclusion Criteria:

* Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
* Subjects with known allergy to warfarin and/or rifampin;
* Subjects who are not homozygous for cytochrome P450 2C9 (CYP2C9 \*1) (known poor metabolizers).
* Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias;
* Subjects with liver failure or liver function test (LFT) results \>2x upper limit of normal;
* Subjects with clinically significant elevations in international normalized ratio (INR), prothrombin (PT), prothrombin time (PTT), serum creatinine (SCr), blood urea nitrogen (BUN) or other screening laboratory tests as determined by study physician;
* Subjects with Hct \<30 mg/dL;
* Subjects with history of GI bleed or peptic ulcer disease;
* Subjects with a recent history of trauma;
* Subjects with a recent history of or upcoming plan of surgery;
* Subjects who smoke tobacco;
* Subjects with ongoing alcohol or illegal drug use;
* Subjects who are pregnant, lactating or attempting to conceive;
* Subjects unable to maintain adequate birth control during the study;
* Subjects unable to follow protocol instructions or protocol criteria.
A Study to Learn More About the Safety of Ultravist in Children and in the Elderly

Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety.

Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults.

The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study.

All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.


Eligibility Criteria:
Inclusion Criteria:

* We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.

Exclusion Criteria:

* Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.
Comparison Between Two Different Protocols in Polycystic Ovary Symdrome Women Undergoing Intra-cytoplasmic Injection

Stein and Leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), After women diagnosed with Stein-Leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive. As a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.


Eligibility Criteria:
Inclusion Criteria:

1. Women under 35 years with polycystic ovary syndrome criteria
2. Normal male semen parameters
3. Normal tubes either by hysterosalpingography \&/or laparoscopy
4. Free from other endocrine abnormalities

Exclusion Criteria:

1. NON polycystic ovary syndrome Criteria
2. More than 35 years
3. Abnormal semen parameters
4. Pathological tube\& pelvic factor
5. Other endocrine disorders