cyrilzakka/clinical-trials huggingface dataset:
The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)

The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.

After being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. After eligibility criteria was verified, an initial wound assessment examination was performed. Subjects were then randomized to the Irrisept or Standard of Care treatment group. Forty-eight hours later, wound progression and signs of infection were assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 80
2. Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.
3. Patient able to provide an informed consent.
4. Patient volunteers to participate.

Exclusion Criteria:

1. Wound was caused by human or animal bite.
2. Wound is a blunt crush injury or has tendon, bone, or joint involvement.
3. Diabetic foot infection.
4. Anticipated incision size less than 5mm.
5. Abscess extends to the muscle layer.
6. Admission to hospital for any reason, including IV antibiotics.
7. Clinical signs of systemic infection on initial patient encounter.
8. Prior history of allergy or hypersensitivity to CHG.
9. Neutropenic (known ANC\<500/mm3), HIV (known CD4\<50), or other severely immunocompromised state (e.g., receiving chemotherapy).
10. Patient is diagnosed with systemic lupus erythematosus or other immunological disease.
11. Currently in police custody.
12. Patient withdraws from participation.
13. Patient unable or unwilling to give informed consent.
The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients

The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg iv during a painful and unavoidable intervention in critically ill patients.

In 2006, in the Intensive Care Unit (ICU) of the St. Antonius Hospital an analgesia improvement program has been implemented. This program consisted of training of ICU nurses and intensivists using a hospital based standardized pain protocol, and systematic pain measurements in rest, rated by the patient himself whenever possible or otherwise by the attending nurse. This program has resulted in a reduction of severe pain levels (NRS≥4) in ICU patients in rest from 41% to 22%. In order to further reduce this percentage, a pain titration protocol is introduced in 2007. As no attention has yet been paid to intervention-related pain levels in these patients, in this prospective study pain control will be studied using different analgesic dosages of morphine iv (2,5 mg vs 7,5 mg) around unavoidable painful interventions within a pain titration protocol for pain control in rest.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.

Exclusion Criteria:

* Pregnancy/ breastfeeding
* Language barrier
* Known morphine iv allergy
* Comatose patients (cooled)
* Patients who are suspected to be brain-dead
* Unintubated patients on the verge of intubation due to respiratory insufficiency
Anakinra in the Management of COVID-19 Infection

Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes.

Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.


Eligibility Criteria:
Inclusion criteria:

* Hospitalized adult (age ≥ 18yrs)
* Confirmed COVID-19 diagnosis
* Presence of respiratory distress in addition to signs of cytokine release syndrome
* Radiological evidence of pneumonia
* Signed informed consent

Exclusion Criteria:

* Known allergic reactions to the study medication or any component of the product.
* Active bacterial, viral, TB, fungal infectious diseases
* Received immunosuppressant or immunomodulatory in the past 30 days
* Neutrophil count \< 500 cells/microliter
* Platelets \< 50,000/microliter
* Pregnant or breastfeeding females
ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.

This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator
* Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length.
* Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.
* Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.

Exclusion Criteria:

* AMI within 1 week.
* Subject has congestive heart failure or NYHA IV.
* Subject with LVEF \< 35%.
* Subject has undergone heart transplantation.
* Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.
* Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding.
* Subject with a history of leukopenia (white blood cell count of \< 3×109/L for \>3 days), neutropenia (ANC\<1000/mm3 for \>3 days) or thrombocytopenia (platelet \<100,000/mm3).
* Known renal insufficiency (eGFR\<30 ml/min).
* Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel.
* Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up.
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
* Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
* Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases.
* Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.
Effects of Virtual Reality in TKA Patients

The goal of this clinical trial\] is to investigate the effects of virtual reality (VR) in patients undergoing total knee arthroplasty (TKA). The main questions it aims to answer are:

* Does VR have effects on pain, kinesiophobia, and function during the early rehabilitation period of patients who have undergone TKA
* Does VR contribute to the success of exercise treatment after TKA

All the patients included in the study were informed about the disease, the goals of post-surgical rehabilitation, the conditions to be considered after TKA and exercises. Sitting on the side of the bed and mobilization in or out of the room with a walker were provided with the postoperative 1st day exercises. The patients were discharged 2.5 days after surgery. The patients in both groups were taught an exercise program for home practice.

In addition to the exercise program, the virtual reality application was applied before the exercises to the VR group. The second evaluation was made 3 days after the end of the treatment in both patient groups.

Researchers compared VR and exercise to see if pain, kinesiophobia, pain catastrophizing, knee range of motion, function, and quality of life had changed.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 50 and 70
* Being female
* Having received TKA due to being at stage III or IV according to the Kellgren-Lawrence Osteoarthritis Classification
* Having sufficient eyesight
* Having kinesiophobia and pain catastrophizing

Exclusion Criteria:

* Having undergone bilateral knee arthroplasty/revision knee arthroplasty
* Vertigo or motion-sensitive nausea
* Being diagnosed with an additional neurological, rheumatological, or oncological disease
* Having a Mini Mental Test score of less than 24
* Being diagnosed with severe anxiety by a specialist physician
* Inability to complete the treatment program
Local Anesthetic Treatments for Overactive Bladder

The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).

Existing first-line treatments for overactive bladder are limited by requirements for chronic dosing and associated systemic side effects. Small case series suggest that bladder instillation of lidocaine may be effective in downregulating the afferent neuronal activity of a sensitized bladder, leading to elevation of the urge sensory threshold and decreasing detrusor activity. However, neither the effectiveness over placebo nor the durability of the response has been previously investigated.

Comparison(s): We propose a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized lidocaine instillation decreases symptoms of overactive bladder more than instillation of normal saline using a validated outcome instrument, the OAB-q.

Eligibility Criteria:
Inclusion criteria:

* Female patient, 18 years of age and older
* Overactive bladder defined as:

  * Urinary frequency defined as eight or more voids in a 24 hour period \> 50% of days of the week
  * Symptoms of urgency
  * Symptoms of at least three months duration

Exclusion criteria:

* Positive urine culture in the past month, or more than 3 episodes of bladder infection in the last 2 months
* Stress or overflow urinary incontinence (determined by clinician) if more than 14 episodes of urinary incontinence per week; also insensate incontinence
* Pregnancy
* Seizure disorder or clinically significant renal disease, allergy to lidocaine, uninvestigated hematuria, or history of urinary/reproductive tract malignancy
* Post-void residual more than 200 cc
Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247

This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). This study is being done for the following purposes:

1. to identify new adverse events,
2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial,
3. to record wound status, and
4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-032 Trial.

About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.

Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events.

Eligibility Criteria:
Inclusion Criteria:

* The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.
* Subject was randomized in 802-247-09-032 and received at least one application of test article.
* Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.

Exclusion Criteria:

* Subjects who refuse to provide written informed consent for this study will be excluded from this study.
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis

A safety study of ANK-700 in patients with relapsing remitting multiple sclerosis. The study has two parts:

Part A - first in human study in which patients receive a single dose of ANK-700 Part B - patients will receive three doses of either ANK-700 or placebo

Study ANK-700-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of ANK-700 in patients with relapsing remitting multiple sclerosis (rrms).

An overview of the two parts and proposed dose groups is given below:

Part A (SAD): Patients will receive a single dose of ANK-700. Part B (MAD): Patients will receive three doses of either ANK-700 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at screening
* Neurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (ICF)
* Either not currently receiving disease modifying MS therapy, or currently using fumarate drugs (dimethyl fumarate or diroximel fumarate)
* Patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study Investigator
* Patient has signed and understands the ICF

Exclusion Criteria:

* Diagnosis of primary progressive MS or secondary progressive MS
* Uncontrolled or significant medical conditions (including active infection or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
* Patients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dose
* Patients treated with sphingosine-1-phospate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dose
* Patients treated with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or IV gamma globulin within 12 months prior to first dose
* Patients treated with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose
* Patients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies for MS
* Contraindication to or inability to undergo gadolinium-enhanced magnetic resonance imaging (MRI) scan
* Use of any investigational drug or experimental procedure within previous 6 months that would interfere with the assessment of ANK-700
* Patients who are pregnant or breastfeeding
* Patients receiving any vaccination within 28 days prior to first dose
* Patient does not agree to limit alcohol intake to 2 drink equivalents or less per day during the study
Del Nido Cardioplegia Randomized Trial

The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow for prolonged re-dosing intervals while providing equivalent myocardial protection. The use of del Nido solution has been used extensively in congenital heart surgery for over 25 years. The primary objective is to determine whether expanding this technique to adult cardiac surgery will confer significant benefits in both surgical workflow and patient clinical outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional recovery or clinical outcome, and (2) superior delivery to the current blood-based cardioplegia strategy in cost analyses.

This prospective randomized controlled trial is designed for adult patients between the ages of 19-79 presenting for isolated CABG or single valve surgery, with or without CABG, requiring the use of Cardio-Pulmonary Bypass (CPB). Patients with previous cardiac surgery or requiring mechanical and pharmacologic support will be excluded from the study.

Subjects randomized to the intervention group will receive del Nido cardioplegia solution during the aortic cross clamp period. The control group will receive whole-blood cardioplegia according to the Inova Fairfax Adult Cardioplegia protocol. Primary outcomes include clinical indicators for myocardial preservation such as serum troponin levels and the return of spontaneous rhythm. Surrogate primary endpoints for myocardial protection include the requirement for inotropic support and the need for defibrillation after coronary reperfusion. Secondary endpoints include post-operative clinical outcomes, duration of the aortic cross clamp period, and total expenses incurred during the patient length of stay.

The investigators will conduct non-inferiority analyses to examine the effect of cardioplegia treatment arm on clinical outcomes and complications. Analyses of binary outcomes will use a 5% non-inferiority margin and analyses of continuous outcomes will use a 10% non-inferiority margin.

Eligibility Criteria:
Inclusion Criteria:

* Subjects able to receive and provide informed consent
* Elective surgical procedures requiring CPB and myocardial arrest
* Isolated coronary artery bypass graft (CABG) surgery or single valve surgery, with or without CABG

Exclusion Criteria:

* Previous cardiac surgery
* Patients with preoperative inotropic pharmacological support
* Patients on preoperative mechanical circulatory support
* Patients with an implanted pacemaker or implantable cardioverter defibrillator
* Patients with non-isolated CABG or other non-CABG procedures with single valve surgery
Diagnostic Accuracy of Point of Care Test of First Voided Urine Compared to Midstream Voided Urine in Primary Care

The aim of this study is to determine if sampling technique of urine affects diagnostic modalities in primary care. Furthermore it aims to determine if there is difference in the accuracy of the point-of-care test, when the urine sample is stored at room-temperature and analyzed later in the day.

125 patients with one or more symptoms of urinary tract infections, contacting their GP, are asked to make 2 urine samples from the same void. The patient is asked to void firstly in one cup, approximately 10-20 ml., then stop voiding. Then the patient is asked to void the rest into a second cup. This way there is collected both a first-void and a midstream-void from the same patient and the same void.

All the samples are analyzes using urine-dipstick, microscopy and point of care test urine culture. The urine of the midstream void is sent to a Microbiology lab for analyzes as well. Furthermore the test are analyzes again after 1 and 4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of urinary tract infection

Exclusion Criteria:

* Men
* Pregnancy
* Children
* Unable to understand the verbal and written guide
Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years

In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. This study will focus on children aged from 3 to 14 years in age treated by their doctor with the herbal drug Iberogast for their stomach and intestine complaints for one week. Researcher want to learn more about the efficacy of Iberogast by observing the changes of symptoms related to the stomach and intestine disorders. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected.


Eligibility Criteria:
The selection of the children to be documented was the sole responsibility of the physician whereby the information of the Rome III criteria on functional gastrointestinal diseases in children as well as the prescribing information on Iberogast could be consulted as guideline. Only the therapeutic necessity was determining for the use of all medicines. The treating physicians received standardised information regarding the ailment picture (Rome III criteria) before the beginning of the study and during the investigator meetings.
Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury

The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled lidocaine and the effectiveness of aerosolized lidocaine versus instilled normal saline before ETS in attenuating the increase of intracranial pressure (ICP) in severe head injured children and to evaluate the feasibility of a trial involving instilled lidocaine and aerosolized lidocaine for the management of ETS and to evaluate the safety of nebulized lidocaine in traumatic brain injury (TBI) compared to instilled lidocaine and instilled sodium chloride (NS).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the PICU of Memorial Hermann Children's Hospital
* Severe TBI with a Glasgow Coma Scale score 4-8
* Intubated and mechanically ventilated with an ICP monitor in place.
* Continuous invasive monitoring of arterial pressure
* Hemodynamically Stable, defined by normal blood pressure for age before the ETS. We will not exclude patients with norepinephrine to maintain goal blood pressures to maintain Cerebral perfusion pressure(CPP).

Exclusion Criteria:

* Patients with sustained ICP \> 25 for more than 30 minutes mm Hg despite medical or neurosurgical intervention
* Moderate/Severe Acute respiratory distress syndrome (ARDS) with an oxygenation index \> 8
* Pulmonary hemorrhage
* Patients receiving neuromuscular blockade
* Use of other vasopressors for other causes of shock (cardiogenic, hypovolemic and septic)
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures


Eligibility Criteria:
Inclusion Criteria:

* Subjects completed Study YKP3089C035 by SK Life Science.

Exclusion Criteria:

* Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).
* Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
Radiostereometric Analysis of Spine Arthrodesis

The primary objective of this pilot study is to determine the precision of post-operative radiostereometric measurements for the assessment of lumbar spinal fusion. This study will also determine the potential for RSA as a more precise and accurate means for assessment of lumbar spinal fusion and diagnosis of pseudarthrosis.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic degenerative disc disease of the lumbar spine indication surgical intervention
* Scheduled to undergo lumbar fusion surgery
* Patients between the ages of 18 and 75
* Ability to give informed consent

Exclusion Criteria:

* Pregnant women