cyrilzakka/clinical-trials huggingface dataset:
Study of Biostate® in Children With Von Willebrand Disease

This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand disease (VWD) in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 0 and \<12 years of age
* Diagnosed with VWD Type 1, 2A, or 3
* Desmopressin acetate (DDAVP) treatment is ineffective, contraindicated, or not available for subject
* von Willebrand factor: ristocetin cofactor (VWF:RCo) is \<20% at screening or the subject has a history of VWF:RCo \<10%
* Evidence of vaccination against hepatitis A and B or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunization
* Written informed consent given

Exclusion Criteria:

* Active bleeding immediately prior to initial PK period
* Received treatment with DDAVP or a VWF concentrate product for their VWD in the 5 days prior to their first study treatment
* Have received aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days of commencing the PK period.
* Known history or suspicion of having VWF or FVIII inhibitors
* Acute or chronic medical condition, other than VWD, which may affect the conduct of the study
* Known or suspected hypersensitivity or previous evidence of severe side effects to other FVIII/VWF concentrates
* Participation in a clinical study or use of an investigational compound in another study in the 3 months preceding study start
* Unwillingness and/or inability to comply with the study requirements
Cervical Cerclage Position Throughout the Pregnancy.

Cervical cerclage is an obstetric intervention used in women with poor obstetric histories. After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. .

Cervical cerclage is an obstetric intervention used in women with poor obstetric histories due to late abortions, premature deliveries and painless dilatation. These 3 situations are usually due to cervical incompetence though can be caused by infection and other factors.

The cerclage is usually placed from 12-24 weeks of gestation depending on the indication and medical follow up during pregnancy. There are 2 methods for cerclage performance-McDonald and Shirodkar that have the same efficacy.

After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. Each follow up will include a vaginal examination and trans vaginal sonography. The trans vaginal sonography will examine total cervical length, funneling, and the cerclage's distance from the inner and outer os' of the cervix.

Eligibility Criteria:
Inclusion Criteria:

* Women that have a cervical cerclage placed during pregnancy at the investigator's medical center.

Exclusion Criteria:

* Women that do not require cervical cerclage.
* Women that had a cervical cerclage placed at a different medical center.
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are \> 50,000.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
* If Subject is \> 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
* Subject has received at least 1 prior therapy for ITP
* Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
* Subject (or legally-acceptable representative) is willing and able to provide written informed consent

Exclusion Criteria:

* Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
* Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
* Subject has a known hypersensitivity to any recombinant E coli-derived product
* Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
* Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
* Subject is pregnant or breast feeding
* Investigator has concerns regarding the subject's ability to comply with the protocol procedures
Transcranial Ultrasound Via Sonolucent Cranioplasty

Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.

Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI \& CT) in a prospective, quality control study.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.
4. Male or female, aged ≥ 18.

Exclusion Criteria:

1. Patients who are pregnant
Evaluating Nine-Year Sustainability After Implementing Evidence-Based Practices to Prevent Urinary Tract Infections and Overfilling of the Bladder in Patients with Hip Fracture

This study focuses on evaluating the long-term sustainability of a urinary catheter care bundle designed to prevent urinary tract infections and bladder distension in patients undergoing surgery for hip fractures. The intervention, which included two key innovations-a urinary catheter certificate and a nurse-driven urinary catheter protocol, was implemented between 2015 and 2020 and successfully reduced urinary tract infections and bladder distension, previously published. However, due to the pandemic, the initiative was paused and had to be reintroduced in 2022. Now, the study aims to assess the effectiveness of these preventive measures 9 years after their initial implementation. The research will analyze changes in the incidence of urinary tract infections, bladder distension, catheterisation methods, and documentation practices in patients aged 65 and older. The findings will help inform healthcare policies and may have broader implications for preventing adverse events in other surgical patient groups


Eligibility Criteria:
Inclusion Criteria:

-Hip fracture surgery at the study site, age 65 years and older and cared for in the ortho-geriatric wards.

Exclusion Criteria:

-No catheterisation during hospital stay
Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity

This study aims to compare the efficacy of nasal provocation test with Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms

Exclusion Criteria:

* Patients who cannot discontinue drugs before the test as follow

  * Nasal corticosteroids/Oral corticosteroids/Leukotriene modifiers for 1 week
  * Short-acting antihistamines for 3 days
  * Nasal a-mimetics/Oral a-mimetics/Local cromones for 24 hours
* Contraindicated for nasal provocation test: pregnant, exacerbation of allergic rhinitis/asthma, having upper respiratory tract infection within 2 weeks prior to the test, having nose surgery within 8 weeks prior to the test, having severe systemic disease(s)
* Having factors interfere nasal provocation test with Lysine-ASA such as massive nasal polyp, nasal septal perforation, total nasal obstruction at least 1 nostril
Karate or Kung Fu?

Sedentary lifestyle in Asian children together with aversive parenting style may compromise their physical and psychological health. The aim of the proposed stratified, randomized controlled study are to explore the beneficial effects of Japanese martial art (karate) and Chinese martial art (Ving Tsun kung fu) training on improving the psychophysical health in this population. Over fifty-two Asian children (age = 6-12 years) will be recruited from schools in Hong Kong and then randomly assigned to either a karate group or a Ving Tsun group. Children in both groups will receive the respective physical and spiritual martial art training for 3 months (3 times/week, one hour each). Outcomes will be evaluated at baseline and after the intervention by a blinded assessor. Primary outcomes include muscle power of the arms and legs as measured by a medicine ball throw test and a standing long jump test, respectively. Secondary outcomes include flexibility as quantified by a sit-and-reach test, aggression as measured by the Reactive-Proactive Aggression Questionnaire, and attention as measured by the Child Behavioral Checklist-Youth Self-Report. Both karate and Ving Tsun kung fu training programs are predicted to improve physical health of Asian children. It is expected that these training programs can be incorporated into the physical education classes or extracurricular activities in schools or in the community to improve project sustainability.


Eligibility Criteria:
Inclusion Criteria:

* 6-12 years old
* Asian ethnicity and reside in Hong Kong

Exclusion Criteria:

* any physical or psychological disorders that may affect test results
* previous experience in martial arts
* participate in regular sports training
Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures

Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Target controlled infusion technique is used to deliver adequate propofol concentration in plasma.


Eligibility Criteria:
Inclusion Criteria:

• 18 years of age

* Written informed consent
* Ability and willingness to give written informed consent
* American Society of Anesthesiologists (ASA) risk score I-II

Exclusion Criteria:

* Denial of the patient
* Patients ASA physical status III- IV
* Pregnancy
* Volunteers with history of neurological disease or stroke
* Volunteers with a history of recreational drug abuse
* Volunteers with a history of alcohol abuse
* Known drug allergies
* History of adverse events during general anesthesia
* Total intravenous anesthesia not practicable
Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 35-65 years old.
2. Chronic coronary artery disease with coronary Stenosis detectable by percutaneous coronary intervention (PCI). Ineligibility for percutaneous revascularization, as assessed by coronary arteriography. Ineligibility for percutaneous revascularization procedures was determined by 2 expert committees: a surgical committee comprising 2 cardiovascular surgeons and a noninvasive cardiologist, and an interventional committee comprising 2 interventional cardiologists and 1 noninvasive cardiologist.
3. MRI confirmed that chronic coronary artery disease and ischemic regions.
4. Left ventricular ejection fraction (LVEF)≤40%.
5. NYHA Class II-IV.
6. No organ dysfunction for lung, liver and kidney.
7. Patients are able and willing to observe therapeutic effect and adverse events.
8. Signed informed consent.
9. Negative serum pregnancy test.
10. No coagulation dysfunction.
11. Glycated hemoglobin ≤6.5.

Exclusion Criteria:

1. Lactating or pregnant woman.
2. Ineligibility for CABG.
3. Unexplainable baseline laboratory abnormalities.
4. Sensitivity to any of the study medications.
5. Acute myocardial infarction within 1 months of enrollment in the study.
6. Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation.
7. History of life threatening allergic or immune-mediated reaction.
8. Systemic infection or severe local infection.
9. Shock or MODS or patients cannot cooperate with doctors.
10. Severe heart, lung, liver or renal dysfunction.
11. Taking medicine that might have effect on outcomes assess.
12. Suffering HIV, Hepatitis B or Hepatitis C.
13. Participation in any clinical trial in recent three months.
14. History of mental illness or suicide risk.
15. High expectation or unrealistic demands.
16. Recently suffered a lot of radiation exposure.
17. Previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival.
18. Patients with serious complications of coronary artery disease (e.g., perforation of interventricular septum and ventricular aneurysm and mitral regurgitation due to papillary muscle dysfunction).
19. Abnormal coagulation function.
20. Patients with hemodynamic instability which may lead to serious complications.
21. Any condition that, in the judgment of the investigator, would place the patient at under risk.
COVID-19 Serology and Immunosenescence

This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors.

This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Residents of the EHPAD/USLD St Victor of the Amiens CHU who took part in the screening campaign (RT-PCR and serology) organized by the Amiens CHU
* residents who signed a consent form to participate in the study

Exclusion Criteria:

* The patient or his legal representative refused to participate in the study
* Heavily sedated patients
Cystatin-C C-guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project

Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.

This is a prospective, quality improvement study that evaluated critically ill patients initiated on intravenous vancomycin. Between January 2012 through October 2013, vancomycin was dosed at 15-20mg/kg at an interval guided by creatinine clearance using the Cockcroft Gault equation (control arm). Steady state trough concentrations were assessed prior to the 4th dose of a consistent regimen and compared to the individualized target trough range (10-15mg/L or 15-20mg/L) appropriate for the suspected or documented source of infection. Given low overall trough achievement observed with standard care, a quality improvement project was undertaken. After approval by local clinical practice committees with representation from the Division of Infectious Diseases, Pharmacy and Critical Care, a quality improvement project was undertaken to implement a new vancomycin dosing nomogram with dosing intervals based on the Chronic Kidney Disease Epidemiology Collaborative (CKD-EPI) creatinine-cystatin GFR equation, expressed in mL/min. After structured education was provided, the dosing algorithm was rolled out from December 2013 through May 2015 (intervention arm). Steady state target vancomycin trough achievement was compared between study arms with and without adjustment for potential confounders.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in one of three intensive care units at Mayo Clinic in Rochester, Minnesota
* Suspected or documented gram-positive infection
* Prescribed IV vancomycin at a consistent dose and scheduled with 8, 12, or 24 hour Vancomycin dosing interval

Exclusion Criteria:

* Vulnerable population
* Received greater than 1 dose of Vancomycin in the 96 hours before ICU admission
* Baseline glomerular filtration rate (GFR) of less than 20 milliliters/minute
* Undergoing renal replacement therapy
* Body mass index \> 40kg/m2
* Weight \< 40kg
A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to participation
* Female and male patients ≥40 years of age
* Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines

Exclusion Criteria:

* Patients with contraindications according to Spiolto® Respimat® SmPC
* Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
* Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
* Pregnancy and lactation
* Current participation in any clinical trial or any other non-interventional study of a drug or device.
Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?

A parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous IV ferric carboxymaltose and IM hydroxycobalamin supplementation in anemic Indian HD patients


Eligibility Criteria:
Inclusion Criteria:

* All adult prevalent HD patients on HD for at least 3 months with hemoglobin \< 11 g/dL

Exclusion Criteria:

* Blood transfusion, blood loss, infection, surgery or change in haemoglobin by \> 1 g/dL in the last 1 month
* Hemoglobinopathy
* Cirrhosis
* Hematological malignancy or myeloproliferative disorder
* HIV, HBV or HCV infection
* Any chronic inflammatory disorder
* IV iron or oral/IM B12 received in the last 3 months
* Severe hyperparathyroidism (intact parathyroid hormone \> 1,000 pg/mL)
* Pregnancy
* Age \< 18 years
* History of asthma or eczema, any history of drug allergy, including allergy to iron preparations
* History of exposure to chemotherapy or cytotoxic drugs - 5-FU, hydroxyurea, hydroxycarbamide, methotrexate, trimethoprim, colchicine, azathioprine
* History of G-CSF use in the last 1 month
* General anaesthesia with nitrous oxide in the last 1 month
Pilot Social Support Counseling Intervention for Kidney Transplant Candidates

Feasibility pilot social support counseling intervention for kidney transplant candidates

Individuals who are eligible for kidney transplant will be randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a second counseling session along with members of their social support networks. The interventional counseling will then complete the survey (same as control group). Survey answers will be recorded within REDCAP.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18-80
* Being considered for kidney transplant
* Part of social support network for an individual being considered for kidney transplant.
* Physically and Mentally able to participate.