cyrilzakka/clinical-trials huggingface dataset:
Hospital Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic Over Time

This is a retrospective, multicentre, observational study to assess the trends in antibiotic utilization and hospital ecology with respect to susceptibility patterns of selected bacterial isolates to the utilized antibiotics.

This is a retrospective, multicentre, observational study to assess the trends in antibiotic utilization and hospital ecology with respect to susceptibility patterns of selected bacterial isolates to the utilized antibiotics.

There will be two sets of data collected: Hospital acquired infection (only the first pathogen cultured of each episode) and All infection (the whole hospital susceptibility data)

Primary Objectives:

1. To study the impact of the introduction of ertapenem on the susceptibility pattern of various pathogens to imipenem/meropenem.
2. To study the impact of the introduction of ertapenem on the susceptibility of all Gram negative bacilli to antimicrobial agents commonly used in the participated study sites.
3. To explore the trend in antimicrobial utilization before and after the introduction of new antimicrobial agents to the hospital formulary during the index period.

Secondary Objectives:

1. To study the trend of antimicrobial susceptibility to ESBL-producing Enterobacteriaceae during the index period
2. To study the impact of the introduction of other newly introduced antibiotics (e.g., tigecycline) on the susceptibility pattern of various pathogens to carbapenems
3. To study the prevalence and trend of Pan drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa resistant during the index period

Exploratory objectives:

1) To explore the resistant rates of ESBL-producing Enterobacteriaceae, Pan drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in different hospitals after adjusted DDD.

Hypotheses:

1. There will be no increase in the utilization rates of other antibiotics, specifically the other carbapenem drugs (imipenem, meropenem) in the index period (2-3 years before and 2-3 years after the introduction of ertapenem).
2. The introduction of ertapenem to the institution formulary will not negatively impact the susceptibility of selected bacterial isolates to the other carbapenem antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* the susceptibility of Pseudomonas aeruginosa
* the susceptibility of Escherichia coli (ESBL and Non-ESBL producing strains)
* the susceptibility of Klebsiella pneumoniae(ESBL and Non-ESBL producing strains)
* the susceptibility of Enterobacter cloacae
* the susceptibility of Enterobacter aerogenes
* the susceptibility of Acinetobacter baumannii
* antibiotic utilization data of carbapenems: Ertapenem, Meropenem, Imipenem
* antibiotic utilization data of Penicillins: Piperacillin/Tazobactam
* antibiotic utilization data of cephalosporins: Ceftriaxone, Cefotaxime, Flomoxef, Cefoperazone, Ceftazidime, cefepime, Cefpirome
* antibiotic utilization data of Aztreonam,
* antibiotic utilization data of fluoroquinolones: Ciprofloxacin, Levofloxacin
* antibiotic utilization data of aminomethylcyclines: Tigecycline
Abdominal Massage in Enteral Nutrition Patients

Complications related to the gastrointestinal system may arise in patients receiving enteral nutrition through continuous and bolus infusion. These complications include constipation, diarrhea, nausea, vomiting, abdominal distension, increased gastric residual volume, and abdominal pain. The aim of this study is to determine the impact of abdominal massage applied to patients receiving enteral nutrition through continuous or bolus infusion on gastrointestinal system functions. For this purpose, 164 patients meeting the inclusion criteria will be randomized, and four groups will be defined. Half will constitute the experimental group, and the others will form the control group. In our study, the effects of massage on symptom control will be evaluated by comparing symptoms in patients receiving both forms of nutrition. Thus, the evaluation and control of medical conditions (symptoms) such as constipation, diarrhea, vomiting, increased abdominal distension, and increased gastric residual volume are targeted.


Eligibility Criteria:
Inclusion Criteria:

* Patients in intensive care
* Those aged 18 and above
* Patients being fed through a nasogastric tube
* Patients on the first day of enteral nutrition
* Patients without wounds in the abdominal region
* Those who have not undergone abdominal surgery in the last 6 months
* Patients not receiving radiotherapy/chemotherapy
* Patients without a diagnosis of bowel obstruction
* Patients without diarrhea and constipation
* Patients with a Glasgow Coma Scale (GKS) \> 3
* Those with an APACHE II score \> 16
* Patients not taking prokinetic agents
* Patients not taking laxative medications
* Patients without any contraindications for abdominal massage (to be determined in consultation with the primary physician)

Exclusion Criteria:

* Patients for whom enteral nutrition is discontinued during the study
* Patients with interrupted enteral nutrition
* Patients who have started prokinetic agents
* The study will be terminated for patients who have started laxative medication.
Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.


Eligibility Criteria:
Inclusion Criteria:

1. Modified Braden Scale score of 14 or less. The Modified Braden Scale score is calculated as follows:

   Braden Scale score (Ranges from 6 to 23)
   * 1 for Low Serum Albumin
   * 1 for Type II Diabetes
2. Anticipated length of stay of at least 4 days
3. BMI \< 35
4. Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf.

Exclusion Criteria:

1. Existing pressure injuries above Stage II and injuries classified as DTI or unstageable
2. Neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction
3. Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction
4. Rhabdomyolysis
5. Use of a Pacemaker
6. Skin breakdown over the gluteal regions that would preclude the use of surface electrodes.
The Effects of Propofol and Thiopental on Nitric Oxide Production and Release in Erythrocytes

Hypotension is frequently encountered during the use of these commonly used intravenous anaesthetic agents (thiopental and propofol). This is thought to be a consequence of their effects on the sympathetic nervous system, myocardial contractility or vascular tone. However, propofol causes a greater fall in systemic arterial blood pressure than any other drug used for induction of anaesthesia. Propofol causes profound vasodilation, whereas its myocardial depressant effect is not clear. The vasodilatation occurs in both arterial and venous systems. The decrease in systemic arterial blood pressure after thiopental induction is mainly due to peripheral vasodilatation caused by depression of the medullary vasomotor centre and inhibition of the sympathetic nervous system. However, how this peripheral vasodilator effect occurs after both drugs and which mediators accompany it have not yet been fully elucidated. In previous studies, it has been emphasised that systemic vasodilation may be related with increased formation of nitric oxide (NO), a small gaseous and lipophilic molecule which plays an important role in the regulation of vascular homeostasis and haemoregulation. It is important to elucidate the mechanisms that may mediate thiopental- and propofol-mediated vasodilatation in future studies in order to help the methods and treatments that can be developed to prevent hypotension caused by these drugs, which are widely used in clinical practice. Therefore, the aim of this study was to investigate the effects of thiopental and profol on erythrocyte NO synthase activity and erythrocyte-mediated NO release.

Male patients aged 18-45 years with ASA (American Society of Anaesthesiologists) class I (normal, healthy person without any disease or systemic problem other than surgical pathology that does not cause a systemic disorder) who applied to the anaesthesiology and reanimation clinic outpatient clinic for preoperative preparation were planned to be included in the study. Women, patients with ASA class \>1, patients with known thiopental/propofol allergy and patients outside the age range of 18-45 years were excluded from the study. Venous blood samples will be taken from the patients included in the study and incubated with thiopental and propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release.All patients included in the study will be informed and their written and verbal consent will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Aged 18-45 years
* ASA (American Society of Anaesthesiologists) class I (normal, healthy person without any disease or systemic problem other than surgical pathology that does not cause a systemic disorder)

Exclusion Criteria:

* Women patients
* ASA class \>1
* Patients with known thiopental/propofol allergy
* Patients outside the age range of 18-45 years
Right Ventricular Function in Heart Failure

Only a few studies evaluated the RV systolic function in the three categories of HF, regarding the importance of understanding changes in RV function on clinical presentation and outcome; it was essential to understand the prevalence and severity of RV dysfunction among the three groups and the degree of correlation between RV with LV systolic function.


Eligibility Criteria:
Inclusion Criteria:

-

Adult patients of both gender who have the followiong criteria :

(i) symptoms with or without signs of HF (ii) elevated natriuretic peptides (BNP ≥35pg/ mL or NT-proBNP≥125pg/mL) (iii) relevant structural heart disease: left ventricle hypertrophy (left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or left atrial enlargement (\>34 mL/m2) or diastolic dysfunction (E/e'≥13 and a mean e' septal and lateral wall \<9 cm/s) were included.

Then patients were classified according to EF into HFpEF\>50%, HFrEF\<40% and HFmrEF \>40% and \<50%

Exclusion Criteria:

Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients with respiratory failure
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* ECOG performance status of 0 or 1
* Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
* Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR mutations or ALK translocations are required to have received prior therapy with appropriate TKI; prior platinum-based chemotherapy is not required for this specific patient population

Exclusion Criteria:

* Prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years
* Known central nervous system metastases and/or carcinomatous meningitis
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
* Breastfeeding or pregnant
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)

The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207 and its primary metabolite M2.

This is an open-label (everyone know the study intervention), single-arm, multicenter trial to explore safety, efficacy and PK of TMC207 in Japanese participants with pulmonary MDR-TB. The participants will receive TMC207 for 24 weeks in combination with individualized BR drugs selected by the Investigator on Day -1. Participants will primarily be assessed for sputum culture conversion at Week 24. Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Must have confirmed pulmonary multi-drug resistant tuberculosis (MDR-TB) infection, which is defined as infection by a strain of M. tuberculosis resistant to both rifampicin and isoniazid (RFP and INH) by previous screening from a TB treatment
* Must have confirmed positive results for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (more than \[\>\] 1+ smear-positive) during the Screening Phase or sputum culture positive for M. tuberculosis within the preceding 3 months
* A women must not be of childbearing potential: postmenopausal or permanently sterilized or otherwise be incapable of pregnancy, or if childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods and a man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
* Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Has any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult or otherwise make the subject a poor candidate for a clinical study
* Has complicated or severe extra-pulmonary manifestations of TB, including central nervous system infection
* Participants with significant cardiac arrhythmia requiring medication
* Participants with the abnormal electrocardiogram (ECG) parameters as defined in protocol
* Has human immuno deficiency virus (HIV) antibody positive during the Screening Phase
Actigraphy and Neonatal Abstinence Syndrome

The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.

Neonatal opioid abstinence syndrome occurs after birth when opioids were used by the mother during pregnancy.

Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items.

Actigraphy allows to measure objectively the newborn motricity. We will analyse the correlation between actigraphy and Lipsitz scoring system in four groups of newborns.

Eligibility Criteria:
Inclusion Criteria:

* Newborn \> 32 weeks of gestation + 0 day

Exclusion Criteria:

* perinatal asphyxia
* 5- minute Apgar score \< 7
* ante or post-natal brain injury diagnosis
* upper arm motor deficit
* hospitalization in intensive care unit
* neonatal respiratory distress
Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis

Growing research evidence supports the effectiveness of mHealth interventions for improving exercise adherence and motivation. The aims of our study are; 1) to develop and design a smartphone application for a structured hand exercise program for patients with RA and to test its usability. 2) Evaluate the feasibility and effectiveness of hand exercise app. This study is a mixed-methods study that aims to investigate the effectiveness of the Mar-HandTherapy app: a qualitative and quantitative study with the iterative design approach.

The long-term beneficial effects of strengthening and stretching for rheumatoid arthritis (RA) for hand programs (SARAH) on functions have been shown in recent studies. Also, recently a usable web-based hand exercise program developed for patients with RA in UK. 1- The aim of our study is to develop and design a smartphone application for structured hand exercise program for patients with RA and to test its usability. 2- Evaluate the feasibility and effectiveness of smartphone app hand exercise app. In our study, a qualitative iterative design approach that includes focus groups of experts/patients was used. The mobile application was designed in 3 phases: PHASE 1: we conducted focus group meetings to compromise the content, feature and design of app in the first phase (Prototype version of smartphone software for RA hand training program/Mar-Hand-Therapy app). Focus Group were consisted two physiotherapist (PT), three hand therapists (HT) working in the field in different rheumatology or hand rehabilitation clinics, two software-computer engineers, 3 patients with RA who had previously participated hand therapy. All focus group members (n=10) and 6 patients used the app for one week. All users filled the usability questionnaire, made the comments and advises. The revised version was tested again for one week. The last revised version completed after two weeks tested. 40 patients diagnosed with rheumatoid arthritis will be included to the study. Participants randomized to digital intervention and waiting list control. After the 6-week digital intervention qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention. The primary outcomes are hand pain and function and exercise adherence.

Eligibility Criteria:
Inclusion Criteria:

* Those diagnosed with rheumatoid arthritis according to ARA criteria
* RA patients with stage 2 or 3 according to ACR criteria
* The first symptoms started at least a year ago and those who are undergoing medical treatment
* Those between the ages of 18-65

Exclusion Criteria:

* Those who are in the inflammatory period
* Those who have had surgery for neurological, orthopedic or other reasons recently
* Those with specified depression or other psychological diagnosis
* Those who have received physiotherapy and ergotherapy in the past year
The Treatment of Glabellar Frown Lines

The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).

This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient females 18 to 50 years of age
* Moderate to severe glabellar frown lines

Exclusion Criteria:

* Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
* Previous treatment with botulinum toxin
* Previous treatment with biodegradable fillers in glabellar area within last 12 months
* Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
* Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
* Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel 2. No limitations on ethnicity apply to Part 2, Panel 1
* Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator
* Body mass index (BMI) of at least 18 kg/m\^2 but no more than 32 kg/m\^2 at screening
* Body weight between 45 kg and 110 kg

Exclusion Criteria:

* Any clinically significant deviation from normal, as judged by the investigator
* Any major surgery within 90 days of study drug administration
* Participation in another interventional clinical trial concurrent with this study

Note: Other protocol-defined inclusion/exclusion criteria apply
Liver Biopsy in Diagnosis Neonatal Jaundice

1. Identification and characterization of histopathological features of liver in cases of PNJ.
2. Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic causes of PNJ.
3. Evaluation of role of liver biopsy as a diagnostic tool in conjunction with clinical and laboratory findings.

Neonatal cholestasis (NC) is described as an early-life defect in bile production or flow that causes the liver to retain biliary substances. Persistent Neonatal Jaundice (PNJ) is the presence of variable degrees of jaundice, choluria and hypocholic or acholic stools for more than 10 days during early months of life. The rate of neonatal cholestasis is estimated to be 1 per 2,500 live births worldwide.

In Egypt, about 20.4% of full-term newborns develop jaundice yearly. Extrahepatic cholestasis(EHC) and intrahepatic cholestasis(IHC) are the two main causes of persistent neonatal jaundice. This division is according to the presence or absence of extrahepatic obstruction to bile flow. Biliary atresia(BA) and idiopathic neonatal hepatitis(INH) are the most frequent etiologies for EHC and IHC respectively.

It is critical to identify the underlying cause of PNJ in order to start the right surgical or medicinal treatment. Early surgical referral is necessary in biliary atresia(BA) to increase success rates. In the case of treatable metabolic diseases, a prompt diagnosis justifies prompt, targeted therapy and a better prognosis.

Despite the development of new diagnostic means and advances in imaging techniques, non-invasive biomarkers and genomic studies, a liver biopsy done at the right time is still an important tool to evaluate and diagnose patients with cholestasis, as it will help to decide the etiology, the prognosis and eventually the treatment of the patient.

The evaluation of liver biopsies in infantile cholestasis disorders is crucial as the histologic features of many of these disorders may overlap and vary with age.

Eligibility Criteria:
Inclusion Criteria:

* All cases presented with persistent neonatal jaundice in the first year of life in 5 years interval (2019-2023), received at Surgical Pathology Laboratory at Assiut University Hospitals, Egypt.

Exclusion Criteria:

* Patients older than one year.
* Patients who underwent liver biopsy in the same age group but were not diagnosed as Persistent Neonatal Jaundice.
* Patients with deficient clinical data.