cyrilzakka/clinical-trials huggingface dataset:
Comparison of PENG Associated with LFCN Block Versus FICB for Multimodal Analgesic Management in THA

Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) has been recommended since it offers the best pain control with low risk of motor block. Pericapsular nerve group block (PENG) with lateral femoral cutaneous block (LFCN) has been proposed as an effective alternative to FIB that offers similar pain control with a considerably lower risk of motor block. The aim of this study is to compare the afore mentioned blocks and determine which one yielded the least degree of quadriceps femoris muscle weakness and the better pain control (the lowest NRS score with least need for opioids).

This single-center, double blinded RCT investigation will be conducted at ASST Nord Milano - Bassini hospital. The study was approved by the ethics committee "Comitato Etico Territoriale Lombardia 3".

Each patient undergoing elective total hip replacement surgery with anterior approach will be subjected (unless contraindicated) to subarachnoid neuraxial anesthesia and immediately afterwards to a peripheral analgesic block: the FIC block or the association of PENG and FCLN block. The choice of block type will be randomized.

At the end of the procedure, a clinician unaware of the anesthetic technique used will assess the degree of residual motor block. Simultaneously, he will assess pain control in terms of NRS (Numerical Rating Scale) and the need for opioid use.

Eligibility Criteria:
Inclusion Criteria:

* elective total hip replacement surgery for non-traumatic hip disease,
* THA (total hip arthroplasty) with lateral approach
* age \>18 years,
* signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed

Exclusion Criteria:

* Non elective THA
* Lack of consent to the procedure
* Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR \> 1.5, aPTT \> 1.5, PLT \< 40.000)
* Documented or suspected allergy to local anesthetics
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.

This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.

Exclusion Criteria:

-
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders

The purpose of the trial is to evaluate the PK, bioavailability, PD, efficacy and safety of MarzAA for on demand treatment and control of bleeding episodes in adult subjects with inherited bleeding disorders.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cohort: FVII deficiency, Glanzmann Thrombasthenia, or hemophilia A with inhibitors
* Male or female, age 12 or older
* History of frequent bleeding episodes
* Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities
* Agreement to use highly effective birth control throughout the study if the subject has childbearing potential

Exclusion Criteria:

* Genotype of FVIID subjects with identified mutations by central lab at screening
* Previous participation in a clinical trial evaluating a modified rFVIIa agent
* Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect, whichever is longer
* Known hypersensitivity to trial or related product
* Known positive antibody to FVII or FVIIa detected by central lab at screening
* Be immunosuppressed
* Significant contraindication to participate
Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block

mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care.


Eligibility Criteria:
Inclusion Criteria:

* Residential training students in the first -third grade

Exclusion Criteria:

* No-resident trainees
Comparison of Antibacterial Efficacy of Three Final Irrigants

This study was conducted to determine the antibacterial affect of three different solutions used as final irrigant during endodontic therapy. The investigator's objective was to compare the antibacterial affect of relatively new final irrigant QMix with EDTA and Qmix with EDTA+CHX by evaluating the bacteriological status of the root canal before and after use of the final irrigant.

The aim of this clinical trial is to compare the antibacterial efficacy of Qmix, to 17% EDTA+ Chlorhexidine and 17% EDTA, used as final irrigants, during endodontic procedure.

Endodontic treatment was carried out on 90 necrosed teeth of patients under rubber dam isolation and strict sterilization protocol. The teeth were divided into three groups; A, B and C depending on the type of final irrigant to be used. The chemo-mechanical preparation of all the 90 samples was carried out using ProTaper Universal (Dentsply) File system, and 3% sodium Hypochlorite. All the samples from each group were then irrigated according to the final rinse protocol (FRP). Group A was irrigated with Qmix; Group B with 17% EDTA + 2% Chlorhexidine and Group C (Control group) 17% EDTA.

Three bacteriologic samples were taken during the procedure from each root canal under study in all three groups, using sterile paper points. Sample A was collected after access cavity opening and negotiation of the canal but before chemo-mechanical preparation. Sample B was taken after chemo-mechanical preparation but before the use of the final irrigant. Sample C was collected after the use of final irrigation solution. The samples were collected with sterile paper points and were then transferred to microbiology laboratory in microtubes containing Brain Heart Infusion (BHI) broth within 2 hours of sample collection for obtaining the colony forming unit (CFU) counts.

Eligibility Criteria:
Inclusion Criteria:

* Teeth:

  * Single rooted (One root canal)
  * Necrosed teeth requiring root canal treatment.
  * Teeth with mature apices
  * Permanent dentition
  * Mandibular \& Maxillary
  * PAI category 1 to 4

Exclusion Criteria:

• Teeth:

* Single rooted teeth with multiple canals
* Root canal treated
* Requiring elective endodontic therapy
* With partial necrosis
* Fractured
* Having calcified and obliterated canals.
* Having root resorption
* Root canals which could not be negotiated to full working length with #10 K file
* Having severe periodontitis with exacerbating features (PAI = 5)
* Having grade III mobility
* Patients who took systemic antibiotics in past four weeks.
Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis (MKNFOAD)

The study is a prospective birth cohort study and the purpose is to describe the status of maternal key nutrients(eg. folate and vitamin D) supplementation among pregnancies at early gestation in Shanghai, to find out the association between the level of serum key nutrients and atopic dermatitis (AD) in offsprings during 6 months.

This study based on Shanghai pregnancy population is a prospective birth cohort. The investigators obtain the data of participants' folic acid and vitamin D supplement intake through the questionnaire at 12-14 gestational weeks. And the investigators collect participants' blood samples during gestation to directly detect the biological exposure levels of folate and vitamin D. In the follow-up, skin barrier function is evaluated at time of infant 24-48 hours, 42 days and 6 months. During 6 months from birth, the incidence of AD is investigated on offsprings. This cohort study is aimed to (1) clarify the association between prenatal key nutrients with offspring AD; (2) assess the role of maternal key nutrients in the skin barrier of offsprings. It will be a good evidence for the AD prevention and a meaningful protocol to reduce the incidence of AD by its unique design.Univariate and multivariate association analyses will be performed to identify risk factors to AD by using multivariate logistic regression model.

Eligibility Criteria:
Inclusion Criteria:

* Mother plans to proceed prenatal care and delivery in Minhang Maternal and Children Health Care Hospital
* Offspring plans to stay in Shanghai until 6 months and proceed follow-up in Children's Hospital of Fudan University

Exclusion Criteria:

* none
Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study

The aim of this prospective non-interventional neuropsychological one visit study involving functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.

In different experiments, the modulation of cognitive and motor responses by visual emotional information and the ability to discriminate visual emotional stimuli will be tested using experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI - activations of brain regions known to be involved with emotional processing will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 85 years
* Right handed
* For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years

Exclusion Criteria:

* Cognitive deficits as determined by a MMSE Score \< 25/30
* Depression as determined by a HADS-D Score \> 7
* Anxiety as determined by a HADS-A Score \> 7
* Physical disabilities interfering with the study procedures or impacting outcome measures
* Clinically significant diseases within 7 days prior to the study evaluations
* Contraindications against cranial MRI without contrast
Bladder Cancer Patient-Reported Outcomes

The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship experience that differ by clinical risk at diagnosis. The investigators will collect cross-sectional data from persons with BlCa to identify aspects of health-related quality of life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. Information from this study will be used to develop a new patient education and counseling intervention.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Diagnosed with BlCa within the past 4 years
* Able to read, speak, and understand English
* Able to provide informed consent.

Exclusion Criteria:

* Younger than 18
* Diagnosed BlCa longer than 4 years ago
* Unable to read, speak, and understand English
* Unable to provide informed consent.
Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis

The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis.

The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects from 18-65 years old
* Clinically diagnosed with any type of multiple sclerosis in accordance with the revised McDonald criteria
* With walking ability according to the Expanded Disability Status Scale score (EDSS =6)
* With the objective presence of dizziness symptoms (Dizziness Handicap Inventory = 16)

Exclusion Criteria:

* Blurred vision
* Cognitive impairment (Mini Mental State Examination =24)
* Another neurologic disorder contributing to balance impairment
* Relapse within the last 3 months
* Changes in pharmacotherapy within the last 3 months
* History of vestibular rehabilitation within the last 6 months
* Acute cardiovascular of respiratory illness
* Any other contraindication to physical activity
The Role of Traditional Chinese Medicine in the Treatment of Chronic Childhood Immune Thrombocytopenia (ITP)

Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are aimed to achieve symptomatic relief, do not change the natural course of the disorder and are associated with potential side effects and increase cost. Thus, identifying a new therapy that would decrease the bleeding symptoms, without causing significant adverse effects, could be very beneficial. Preliminary reports demonstrate a beneficial role for Traditional Chinese medicine (TCM) in the treatment of ITP.

Working hypothesis and aims: The use of TCM will improve the status of children with chronic ITP and thus will reduce the need to use conventional medications. The investigators aim to study whether in children with chronic ITP, supplementation with TCM, improves the bleeding symptoms and ITP-related quality of life (QOL) compared to the period prior to the intervention? Methods: The study includes three periods: 1st observation period (1 month), TMC period (3 months) and 2nd observation period (2 months). During all study periods the following data will be collected: bleeding symptoms, bleeding score, platelet count, need for conventional therapy, side effects of therapy and ITP-related QOL.


Eligibility Criteria:
Inclusion Criteria:

1. Children (\< 18 years) diagnosed with chronic ITP; \>1 year after a first diagnosis and baseline platelet count \< 30,000. The diagnosis of ITP will be the responsibility of the Pediatric Hematology specialist in each participating center.

-

Exclusion Criteria:

1. Children with thrombocytopenia due to other causes. 2. Refusal of child or guardian to participate.

-
Smart After-Care in Patients With Prostate Cancer

This study aims to examine whether Smart After-Care service (Internet-and mobile-based lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer on androgen deprivation therapy will participate in the study. The study design is a randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients received Smart After-Care service for 3 months. Primary endpoint was an increase in patients' physical function as assessed using 2 minute walking test. Secondary endpoints included improvement in muscle strength, short physical performance battery, body composition, and health-related quality of life.

After-care is a process targeted towards restoration or maintenance of the physical, mental, intellectual and social abilities of an individual affected by cancer. Internet-and mobile-based lifestyle intervention have emerged as potential modalities to complement and increase accessibility to after-care. In order to meet the growing need for after-care services, we developed a Smart after-care system that will assess the efficacy of a web-based smartphone-enabled intervention. The system provided specialized tools on after-care of prostate cancer including information on nutrition, physical activity, medication adherence, and mobile device that can connect to the smartphone. Patients with prostate cancer on androgen deprivation therapy will be screened for having adequate musculoskeletal and cardiopulmonary function.The study design is a randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients received Smart After-Care management for 3 months. Primary endpoint was an increase in patients' physical function as assessed using 2 minute walking test. Secondary endpoints included improvement in muscle strength, short physical performance battery, body composition, and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Males diagnosed with prostate cancer
* Current treatment with ADT (GnRH agonist/antagonist with or without antiandrogen) for a minimum of 6 months after randomization
* Having Android smartphone

Exclusion Criteria:

* Having another (active) malignant disease within 3 month before randomization
* Having severe cardiopulmonary disease
* Having bone pain due to bone metastasis, (or) pathologic fracture
* Receiving total knee replacement arthroplasty, (or) total hip replacement arthroplasty
* No permission from treating/study physician to participate in exercise
A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients

The project will apply the methods of clinical observation experiment to study the central transport characteristics of flurbiprofen axetil by detecting S-flurbiprofen and R-flurbiprofen concentrations in cerebral-spinal fluid(CSF) after intravenous injection of flurbiprofen axetil in elderly patients.

The patients undergoing spinal anesthesia for lower extremity surgery will be studied. Flurbiprofen axetil 100mg will be injected intravenously. CSF 1ml and blood 2ml will be obtained simultaneously every 5 minutes after intravenous injection in 50 min( T1\~T10).CSF and blood samples will be used to detected S-flurbiprofen and R-flurbiprofen concentrations by using Liquid Chromatography-Mass Spectrometry. And the CSF/blood S-flurbiprofen and R-flurbiprofen concentrations ratio were calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lower extremity surgery under spinal or combined spinal-epidural anesthesia will be selected.

Exclusion Criteria:

* asthma, liver insufficiency, renal insufficiency, peptic ulcer, allergy to NSAIDs, and a history use of NSAIDs within two weeks before operation.
Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms

This study will investigate the effectiveness of two oral supplements on the ocular signs and symptoms in symptomatic dry eye patients. Eligible participants will be given one of two oral supplements to take once a day for up to three months.


Eligibility Criteria:
Inclusion Criteria:

1. Is over 19 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and anticipated to be able to comply with the daily intake of liquid oil supplements (one teaspoon per day for three months);
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Exhibit moderate ocular dryness symptoms, defined as:

   1. A score of ≥23 on the Ocular Surface Disease Index (OSDI, (Allergan Inc., Irvine, CA)) questionnaire;
   2. Currently uses, or feels the need to use eye drops to relieve symptoms of dryness.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Currently wears, or has worn contact lenses in the past 3 months;
4. Has sensitivity or an allergy to products that contain fish, soy, coconut oil or olive oil;
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
6. Is using any systemic or topical medications (including topical corticosteroids/NSAIDs or glaucoma medications) that in the opinion of the investigator may affect a study outcome variable;
7. Is currently taking, or has used, any omega-3 or omega-6 supplements in the last three months;
8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
9. Is pregnant, lactating or planning a pregnancy at the time of enrolment;
10. Is aphakic;
11. Has undergone refractive error surgery;
12. Is an employee of the Centre for Contact Lens Research;
13. Has taken part in another (pharmaceutical) research study within the last 30 days;
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer:

* HR-positive (breast cancer cells that need estrogen or progesterone to grow)
* HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface);
* locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body)
* who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease.

Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole.

The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
* Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
* Documented HER2-negative tumor
* Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
* Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1

Exclusion Criteria:

* In visceral crisis at risk of immediately life-threatening complications in the short term.
* Current or past history of central nervous system metastases.
* Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
* Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
* Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.