cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Stewardship in Infectious Disease Departement

Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /

* Pneumoniae
* Urinary tract infection
* Cellulitis
* Meningitis
* Malaria
* Febrile neutropenia
* Febrile acute diarrhea
* Fever back to the tropics
* Angina
* sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..

Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 (setting up protocols) to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /

* Pneumoniae
* Urinary tract infection
* Cellulitis
* Meningitis
* Malaria
* Febrile neutropenia
* Febrile acute diarrhea
* Fever back to the tropics
* Angina
* sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to emergency for infectious syndrome
* Patient \> 18 years old.
* Patient who accept to have his medical records reviewed for research.

Exclusion Criteria:

* Patient \< 18 years old.
A Randomized Controlled Trial of AppS to Home Monitor Your Asthma

The objective of this study is to design, implement, and evaluate the impact of an adapted health information technology(IT)-enabled practice model for asthma symptom monitoring using patient-reported outcomes (PROs) in a primary care setting. Adults over 18 years of age with asthma will be recruited at primary care clinics and randomized to either 1) asthma symptom monitoring via the mobile health (mHealth) app; or 2) usual care. The investigators will collect data on patient-reported asthma quality of life and asthma-related healthcare utilization. We will also study barriers and facilitators to implementation of the mHealth app and health IT-enabled practice model.

The specific aims of this study are:

1. Adapt our existing health IT-enabled practice model for asthma symptom monitoring using PROs to a primary care population. The health IT-enabled practice model is comprised of the following: an mHealth app that can be installed on patients' smartphones that integrates into clinical workflow; and an asthma PRO dashboard in the electronic health record (EHR) for clinicians.
2. Implement the adapted health IT-enabled practice model in 7 primary care community clinics, identify a cohort of eligible asthma patients to participate, and train clinicians and clinical staff.
3. Rigorously evaluate the impact of this new health IT-enabled practice model using a randomized controlled trial study in which we enroll 500 asthma patients (250 intervention, 250 usual care) by primary care clinician. We will measure patient-reported asthma quality of life and asthma-related healthcare utilization (defined as urgent care and emergency room visits and hospitalizations) as our primary and secondary outcomes, respectively. We will use mixed methods to identify barriers and facilitators to implementation and factors that affect sustainable spread and scale as per the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework.

Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking
* 18 years of age
* Regularly uses (most days) a compatible smartphone (iOS or Android)
* Able to provide consent
* Seen for primary care within the last 12 months at one of the 7 outpatient primary care clinics that are part of the Brigham \& Women's Hospital (BWH)/ Brigham \& Women's Faulkner Hospital (BWFH) practice-based research network.
* At least one visit coded for asthma within 12 months prior to screening, including inpatient, emergency department, urgent care/walk-in, and specialist visits.

Exclusion Criteria:

* Deemed inappropriate for study, per judgment of the BWH/ BWFH primary care provider
* Unable to provide consent
Long Term Use of Somatropin in Patients Small for Gestational Age

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Genotropin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Somatropin (Genotropin®).
Multi-parametric MRI in Patients of Bladder Cancer

Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI).

Patients who underwent bladder MRI were retrospectively collected at three centers between January 2013 and September 2023. The investigators first constructed a nnUNet to segment causal region where muscle-invasive bladder cancer may occur. Subsequently, the investigators explored a causal network based on a modified ResNet3d-18 by striking a fine balance between nnUNet awareness and a self-supervised learning (SSL) model, which steered model to emulate diagnostic acumen of expert in staging muscle-invasive bladder cancer at MRI. Model was trained in center 1, and independently tested in center 1, center 2 and center 3. Ablation test was performed among all 13 Ablation-Test models using either single or multi-parametric MRI. Benefit was tested in six radiologists using vesical imaging-reporting and data system (VI-RADS) versus network-adjusted VI-RADS.

Eligibility Criteria:
Inclusion Criteria:

* Urothelial carcinoma of the bladder confirmed by final histopathology ②Received a standard contrast-enhanced 3.0T mpMRI before surgery ③All tumors within patients included were resected and received pathologic examination separately

Exclusion Criteria:

①Absence of surgical interventions

②With inadequate image quality or with inadequate pathology for analysis
Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.

The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
* Inadequate response to topical medications.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* Pregnancy.
* Other.
Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation

This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.

This is an observational retrospective analysis from the main pediatric centers in Italy (approximately 5 sites). The selected sites will be the most representative of Italy because they perform about 2/3 of all allogeneic HSCT per year.

Index date: date of allogeneic HSCT; retrospective data will be captured in consecutive patients undergoing allogeneic HSCT from January 2018 to June 2020 with maximum 12 months of follow-up for each patient. The data of the patients undergoing allogeneic HSCT after June 2020 will not be captured in order to avoid any possible bias due to off-label access to letermovir.

Medical Records (MR) will be used to describe the risk factors, patient characteristics, treatment patterns, and healthcare resource utilization of subjects who had a CMV infection.

Electronic or paper hospital charts (inpatient), clinical charts (inpatient and outpatient), and outpatient records will all be considered as MR for study purposes.

This is a secondary data collection study from electronic or paper medical chart review, no data from registry will be collected.

Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.

Eligibility Criteria:
Inclusion Criteria:

* Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);
* Patients who received allogeneic HSCT between January 2018 and June 2020;
* Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.

Exclusion Criteria:

* Letermovir use at any time
Improving Outcomes of Respiratory Patients With Exertional Hypoxemia

The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.

In this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.

Eligibility Criteria:
Inclusion Criteria:

* 21 years and above
* Presence of exertional hypoxemia during 1-minute sit-to-stand test
* diagnosis of acute COPD exacerbation or Covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease
* physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist

Exclusion Criteria:

* uncontrolled severe medical conditions
* currently enrolled in a pulmonary rehabilitation trial
* unsuitable for randomization as determined by the patient's physician
The Effect of Manual Lymph Drainage in the Treatment of Breast Edema

Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Therefore, it is important to treat and prevent its development. In the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent breast-conserving surgery and received adjuvant radiotherapy
2. Patients with Sentinel Lymph Node Biopsy or axillary lymph node dissection
3. Female patients between the ages of 18-75
4. Patients who cannot read and write Turkish

Exclusion Criteria:

1. A previous cancer
2. Decompensated heart failure
3. Untreated congestive heart failure
4. Active infection
5. Uncontrolled hypertension
6. Acute kidney failure
7. Patients with acute deep vein thrombosis
8. Metastasis and/or recurrence during treatment
9. Patients who have undergone another surgery related to the breast and chest area
10. Patients who develop lymphedema in the upper extremity during therapy will be excluded from the study.
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks

This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.

see below

Eligibility Criteria:
Inclusion Criteria:

* Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH)
* Patients must give written informed consent

Exclusion Criteria:

* A diagnosis of acquired C1INH deficiency (AAE)
Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation

To determine the effect of power walking on quality of life in Post CABG population undergoing phase 2 cardiac rehabilitation


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subject
* Age will be from 50 to 70
* Four weeks after CABG surgery patient are eligible to participate
* Patient able to walk on Treadmill with Cardiac symptoms stable or absent
* Appropriate HR response to exercise

Exclusion Criteria:

* Those patients with contraindications to exercise or clinical risk factors, such as musculoskeletal, neurological, pulmonary or metabolic disorder were all excluded from the study.
Accuracy of Computer-assisted Template-based Implant Placement Using Conventional or Digital Impression

Proper implant position has a significant impact in esthetic and functional outcomes of implant-supported restorations. Computer-assisted template-based implant placement (guided surgery) have become increasingly popular due to improved planning and the higher transfer accuracy of the virtual plan to the surgical site compared with freehand insertion or freehand final drilling. Digital impressions replace the need for traditional materials that can be inconvenient and messy for patients. To the best of our knowledge, at the time of planning this study, there were no published RCTs evaluating a fully digital approach for computer-assisted template-based implant placement.

The aim of the present study is to compare early implant failure, template-related complications, and virtual planning accuracy of computer-assisted template-based implant placement using conventional impression and scan model or digital impression.

The null hypothesis is that there will be no difference between these interventions.


Eligibility Criteria:
Inclusion Criteria:

* fully or partially edentulous patient, aged 18 years or older, able to sign an informed consent, in need of an implant-supported fixed restoration will be considered eligible for this study. Any potential implant locations based on individual patient requirements will be considered eligible in the present trial. No set location or group of locations will be excluded.

Exclusion Criteria:

* general medical contraindication to oral surgery (American Society of Anesthesiologist, ASA, class III or IV); irradiation in the head and neck area less than one year before implantation; psychiatric problems; alcohol or drug abuse; pregnant or nursing; untreated periodontitis; severe bruxism or clenching; uncontrolled diabetes; poor oral hygiene and motivation; and inability to complete the follow-up.
Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 versus NTCB-C in patients who require parenteral nutrition


Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Patients are expected to require PN for more than 3 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 3 days
* Patients BMI is over 30 kg/m2
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients with difficult central venous line
* Patients judged to be unsuitable for this trial by investigators
Pattern of Admission and Outcome of Patients Admitted to the Intensive Care

The study was a retrospective observational cohort where patient medical record review was done and data were gathered on 419 cases. The ICU admission pattern and patient outcome were the primary outcomes presented in the manuscript.

The study was conducted at a teaching University hospital in a low-resource setting retrospectively on admission to ICU over the last five years. samples were selected using a simple random sampling technique to come up with the desired number.

Eligibility Criteria:
Inclusion Criteria:

* complete medical record
* admission to ICU

Exclusion Criteria:

* patients who were transferred or self discharged
Cost-Effectiveness and Clinical Outcomes of Double J Stent Versus Percutaneous Feeding Tube Placement Following Open Pyeloplasty in Pediatric Patients: A Prospective Randomized Single-center Study

Open pyeloplasty is a common surgical intervention for pediatric patients with ureteropelvic junction obstruction. Post-operative management strategies, including the use of a double J stent and a percutaneous feeding tube, vary widely. While both options have demonstrated effectiveness in drainage, their relative clinical outcomes, costs, and overall value in pediatric urology remain unclear. This randomized controlled trial (RCT) aims to compare the clinical efficacy and cost-effectiveness of these two post-operative interventions in pediatric patients undergoing open pyeloplasty.

This is going to be a prospective randomized study of pediatric patients undergoing open pyeloplasty in Department of Pediatric Urology, Institute of Kidney Diseases, Peshawar. After obtaining approval from the ethical committee board of the hospital. The aim and benefits of the study will be well explained to the parents of all the patients, and they will be briefed as well that no risk is involved while participating in this study. Then informed consent will be obtained and the patients will be randomly assigned to receive either a double J stent or a percutaneous feeding tube for post-operative drainage. Randomization will be performed using block randomization to ensure balance between groups. A mix of both consecutive and purposive sampling technique to recruit patient until the desire sample size is reached. The primary outcomes included pain relief, the rate of complications like post op infection, obstruction, and length of hospital stay. Secondary outcomes included incidence of re-operations, and cost analysis of the two interventions. A cost-effectiveness analysis will be conducted from the healthcare provider's perspective, considering direct medical costs (surgical, hospitalization, and follow-up care) and the quality-adjusted life years (QALYs) for each group. Data will be analyses using SPSS and results will be reported

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary PUJO and outflow obstruction on renal Scan who are candidates for elective open pyeloplasty

Exclusion Criteria:

* Patients who are previous operated for PUJO , and having recurrence
A Study for Patients With Complicated Skin and Skin Structure Infections

Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed.

The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory.

SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.


Eligibility Criteria:
Inclusion Criteria

* Complicated skin and skin structure infection, presumed or proven to be caused by gram-positive pathogen(s).
* Patients, ages 18 years and older, must not be below normal body weight or morbidly obese.
* Female patients must not be pregnant at time of enrollment and must agree to a reliable method of birth control during the study and for 6 months following the last dose of study drug.

Exclusion Criteria:

Patients:

* with a condition which would prevent performing protocol safety and efficacy assessments.
* who have received antibiotics for more than 24 hours within the last 3 days.
* with an infection involving deep tissues or unlikely to be caused by gram positive bacteria
* who are nursing and will not stop nursing for at least 6 months
* with a prior allergic reaction to glycopeptides (e.g. vancomycin)
* with any of the following:

  1. toxic shock syndrome or toxic-like syndrome
  2. presumed or proven infection caused by Clostridium species
  3. bone infections
  4. ischemic or gangrenous ulcers or wounds
  5. infections caused only by gram-negative bacteria
  6. infection of an artificial joint that cannot be removed
  7. infection of the scrotum, perineum or perianal region
  8. infection of a severe burn wound
  9. severe ear infection involving bone and/or cartilage
  10. infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel

The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the presence or absence of gastrointestinal (GI) pathogens from human stool specimens.

The objective of this study is to establish diagnostic accuracy of the xTAG GPP.

The xTAG GPP assay is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify bacterial (and toxins), viral, and parasitic pathogens extracted from human stool specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis.

The objective of this study is to establish the diagnostic accuracy of xTAG GPP through a multi-site, method comparison study on prospectively collected, left-over, and anonymized stool specimens. The prospective sample set will also be supplemented with pre-selected archived left-over specimens (for low prevalence targets only). Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each target.

Eligibility Criteria:
Inclusion Criteria:

* The specimen is stool.
* The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
* The specimen is from a patient exhibiting clinical signs and symptoms of infectious colitis or gastroenteritis.

Exclusion Criteria:

* The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.