cyrilzakka/clinical-trials huggingface dataset:
Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

This project aims to reduce antibiotic use in Chinese neonatal intensive care units (NICU) by 1) developing an adaptable framework of NICU-targeted antimicrobial stewardship programs (ASP); 2) implementing the NICU-targeted ASP in NICUs using a collaborative quality improvement method; and 3) evaluating the impact of ASP implementation on neonatal antibiotic use.

Antibiotics overuse has been a critical problem in Chinese NICUs associated with the emerging antimicrobial resistance crisis. NICU-targeted ASP have rarely been implemented in Chinese NICUs. Collaborative quality improvement methods have been shown to facilitate clinical practice changes and improve outcomes.

In this two-year interventional pre-and post-study, a NICU-targeted ASP will be developed and implemented in Chinese NICUs using the collaborative quality improvement method. The investigators hypothesize that implementing the targeted ASP using a collaborative quality improvement method will reduce the overall antibiotic days of therapy by 20% over a two-year period, comparing the last year of intervention and the last year of baseline period before ASP implementation.

Eligibility Criteria:
Inclusion Criteria:

* All infants born at ≤31+6 weeks' gestation and admitted to the participating NICUs between October 1st, 2019 and September 30th, 2023.
* The period from October 1st, 2019 to September 30th, 2021 will be used as the baseline period before ASP intervention. Clinical data of eligible infants in this period will be retrospectively collected from a previously established database of preterm infants.
* The ASP implementation will be initiated on October 1st, 2021. The period from October 1st, 2021 to September 31st, 2023 will be the ASP intervention period and data will be prospectively collected.

Exclusion Criteria:

* Infants who are transferred to non-participating NICUs within 24 hours after birth.
Narrative Exposure Therapy (NET)

The purpose of this study is to learn more about Narrative Exposure Therapy for Justice Involved Veterans. This pilot study will examine the feasibility of this intervention in a justice-involved veteran population, and will see whether the intervention needs to be tailored to best meet their needs. The investigators will examine whether the intervention impacts key clinical outcomes, including posttraumatic stress disorder symptoms, as well as on measures of moral injury, anger, depression, suicidality, and aggression.

The overall objective of this application is to gather data on the use of Narrative Exposure Therapy for Justice Involved Veterans (VETNET) in a pilot sample of justice-involved Veterans with PTSD, with a particular focus on obtaining data on feasibility and acceptability of the intervention in a justice-involved veteran population, and determining what further adaptations are needed to tailor this intervention to justice-involved Veterans (JIV). The investigators are also interested in evaluating whether the intervention has the potential to have an effect on key clinical outcomes, including posttraumatic stress disorder (PTSD) symptoms, as well as on measures of moral injury, anger, depression, suicidality, and aggression.

The following Specific Aims have been developed for this project:

Aim 1: Evaluate study feasibility and treatment delivery procedures of Narrative Exposure Therapy for Justice Involved Veterans (VETNET) in justice-involved Veterans (JIV) with PTSD. Data gathered will include recruitment rates, drop-out rates, adverse event frequency and severity, and participant engagement in treatment. As necessary, identify further adaptations that are needed to tailor this intervention specifically to JIV.

Aim 2: Evaluate the impact of VETNET on PTSD symptoms, as well as on related outcomes including moral injury, anger, depression, suicidality, and aggression.

Eligibility Criteria:
Inclusion Criteria:

* Is a veteran;
* Recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year;
* Meets current criteria for PTSD.

Exclusion Criteria:

* Currently incarcerated;
* Current, active psychosis;
* Is at imminent risk for suicide or homicide warranting immediate intervention;
* Substance abuse that is severe enough to prevent full engagement in the study protocol;
* Concurrent trauma-focused psychotherapy including Prolonged Exposure Therapy, Cognitive Processing Therapy, or EMDR;
* Is unable to unwilling to complete study procedures.
Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy

Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated.

OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico.

Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
* Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA.
* Treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached.
* Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study.
* Participants with physio/physical therapy can be included.

Exclusion Criteria:

* Previously treated with botulinum toxin for spasticity related to cerebral palsy.
* Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission.
* History of hypersensitivity to the study drug or to any of the excipients in the formulation.
* Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration.
* Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration.
* Have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.
Conduit Cages and Fibergraft BG Putty

The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,
3. Pathology of the cervical or lumbar spine.
4. Pathology to be between C2-T1 in the cervical group.
5. Pathology to be between L2-S1 in the lumbar group.
6. Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
7. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Exclusion Criteria:

1. Patients \< 18 years
2. BMI \> 40 kg/m2 to be excluded
3. Patients with a bone density (DEXA) score of \<2.0 to be excluded
4. 3 or more levels for ACDF or Lumbar interbody to be excluded
5. Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
6. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded
Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma

Pirmary endpoint: to examine the feasibility of using an mHealth app for reporting of side effects instead of a telephone call from the hospital staff together with examining the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before. With this innovative method investigator aimed to give the patient more independence in their daily life and in that way improve their quality of life.

It is a prospective, clinical, parallel mixed-method design with a quantitative core and a qulitative supplementary component. There will be used a Mhealth app called "My Hospital".

Quantitative data will be acquired from time registrations performed by patients and nurses and will be descriptively analyzed applying a micro-costing approach, using cost data per individual. Qualitative data will be obtained from individual, semi-structured interviews with patients and one focus group interview with healthcare professionals and will be analyzed applying a hermeneutic approach.

Eligible for inclusion were patients with MM scheduled for Bortezomib. Moreover, patients should have access to a smartphone, be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

Eligibility Criteria:
Inclusion Criteria:

* patients with MM scheduled for Bortezomib
* patients should have access to a smartphone
* patients should be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

Exclusion Criteria:

* patients had to talk and read danish
Finnish Genetic Study for Arrhythmic Events

Finnish Genetic Study for Arrhythmic Events (FinGesture is a prospective case-control study assessing the characteristics and genetic background of consecutive series of autopsy verified out-of-hospital victims of SCD vs. survivors of an acute coronary event in a specific geographical area in northern Finland.


Eligibility Criteria:
Inclusion Criteria:

* Sudden cardiac death verified by medicolegal autopsy (cases)
* Acute coronary event (increased troponin levels/ECG markers of ischemia/angina pectoris; two out of three criteria) (controls).

Exclusion Criteria:

* Sudden death due to other causes (cases).
* Acute coronary event patients who died during hospitalization (controls).
Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1

This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Merkel Cell Carcinoma (MCC)
* ECOG performance status ≤ 1
* MCC in an advanced, unresectable stage III or metastatic stage IV (includes patients who refused surgical resection or are not eligible for such surgical resection)
* Progressing on previous anti-PD-(L)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication

Exclusion Criteria:

* History of serious anti-PD-(L)1 therapy-related adverse reactions prohibiting further avelumab treatment
* More than one line of previous systemic anti-neoplastic therapy other than anti-PD-(L)1 antibody monotherapy
* Palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication
* Presence of significant active or chronic disease (infections, immunodeficiencies, cardiovascular, psychiatric disorders)
Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution

This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution

The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea

Eligibility Criteria:
Inclusion Criteria:

* according to instruction for use

Exclusion Criteria:

* according to instruction for use
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
* Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention

Exclusion Criteria:

* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
* Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
* Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: more than 18 years
* More than 6 months post stroke
* Functional ambulation classification (FAC) (1\~4)

Exclusion Criteria:

* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* Difficult to understand experimental tasks because of extremely severe cognitive impairment
* History of disorders involving central nervous system
* History of psychiatric disease
* implanted objects that would contraindicate tDCS
A Study to Learn About Recifercept in Patients With Achondroplasia

The purpose of this study is to learn about the study medicine (called recifercept) in people with achondroplasia. Achondroplasia is a very rare disease and patients of achondroplasia have short arms and legs. The study will include data already collected from a recifercept clinical trial and data collected from a separate study of achondroplasia. This study will compare patient experiences and will help the investigators determine if the study medicine, recifercept, is effective.


Eligibility Criteria:
Inclusion Criteria:

* All patients from Study C4181005 who have completed Visits 1 through 11 (at D183) will be included in this project.

To construct a concurrent external control, patients from Study C4181001 will need to meet the following inclusion criteria from Study C4181005 to be eligible for inclusion:

* Documented, confirmed genetic diagnosis of achondroplasia from historical medical records (test must have been performed at a laboratory fully accredited for genetic testing under local regulations)
* Aged ≥ 3 months to \<11 years (up to the day before 11th birthday inclusive) at time of enrollment into the observational natural history study.
* Havecompleted at least 2 valid height/length measurements (at least 3 months apart)
* Assessed for Tanner stage 1 during physical examination before or at enrollment (must include assessment of breast development for females, testicular stage for males)
* Able to stand independently for height measurements (if ≥ 2 years of age at enrollment); If aged \<2 years at enrollment, has a documented historical MRI brain/cervical spine performed in the previous 12 months.
* Have at least 6 months of available follow-up data after enrollment into the natural history study

Exclusion Criteria:

* Patients meeting any of the following criteria will not be included in the study:

  * Presence of severe obesity (BMI\>95% percentile on Hoover-Fong BMI charts);
  * Body weight \<7kg or \>30kg
  * History of chronic kidney disease (CKD) or renal impairment
  * History of receipt of any treatment that are known to potentially affect growth (including oral steroids \> 5 days in the last 6 months before enrollment, high dose inhaled corticosteroids (\>800 mcg/day beclametasone equivalent) and medication for attention deficient hyperactivity disorder.
  * Less than 6 months since fracture or surgical procedure of any bone determined from the baseline visit date.
  * Presence of any internal guided growth plates/devices
  * History of removal of internal guided growth plates/devices within 6 months prior to enrollment
Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis

Plantar fasciitis is a common musculoskeletal disorder characterized by inflammation of the plantar fascia, causing heel pain and discomfort. Various treatment modalities have been explored to alleviate symptoms, with Radial Shockwave Therapy (RST) and Graston Instrument-Assisted Soft Tissue Mobilization (IASTM) emerging as promising interventions.This study aims to compare the effectiveness of these two treatments in managing plantar fasciitis. RST offers a non-invasive alternative for individuals suffering from plantar fasciitis particularly crucial for patients who prefer conservative treatments or want to explore less invasive options before considering surgery also stimulate the body's natural healing processes by promoting blood flow and tissue regeneration.

Study Design will be randomized clinical trial. Study setting will be Sehat medical complex Lahore. Study Duration will be 4 months after synopsis approval Sample size will be 40 calculated by Epitool ,intervention group will be Group A: Radial Shock Therapy(RST) , Group B: Graston Instrument Assisted Soft Tissue Mobilization (GIASTM). Purposive sampling technique will be implanted. Both genders (male/female).Age 20 to 45 years, Pre-diagnosed with chronic plantar fasciitis, Heel pain will be included. Patients with rheumatoid arthritis, osteoporosis and ankle and foot bursitis were excluded. VAS scale (visual analogue scale), Foot function index (FFI), 12-Item Short-Form Health Survey and goniometer will be data collection tools. SPSS version 25 will be used for statistical analysis. Shapiro-wilks test for normality will be used to assess the normality of the data after which it will be decided either parametric or non-parametric test will be used within and across the group.

Eligibility Criteria:
Inclusion Criteria:

* Both genders (male/female) Age 20 to 45 (25) unilateral chronic plantar fasciitis of more than 3 months Pre diagnosed with chronic plantar fasciitis soreness and local tenderness bottom of the heel. Searing or piercing type pain (26) Pain greater than four on the visual analogue scale (VAS) during the first steps in the morning(10) gradual development of pain with no trauma(27) pain generated by local pressure(26) Increase in pain in the morning upon taking a few steps or after prolonged non-weight bearing(28) symptoms decreasing with slight levels of activity, such as walking(11) No previous history of radial shockwave therapy or Graston technique for plantar fasciitis

Exclusion Criteria:

- Having lower limb pathology (24) Tarsal tunnel syndrome (TTS) Fat-pad syndrome(11) Have heel spurs(26) Bilateral PF Previous ankle or foot surgery History of topical corticosteroid injections to the ankle or foot Neuropathic or radicular pain in the lower limbs Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, osteoporosis psoriatic arthritis, rheumatoid arthritis, and gout, foot bursitis, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.(25)