cyrilzakka/clinical-trials huggingface dataset:
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia

The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.

PLX-PAD are mesenchymal-like stromal cells derived from a full term placenta, termed PLX-PAD, and intended for the treatment of Critical Limb Ischemia

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI \< 0.4 or/and TBI \< 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmHg pO2 at the foot.
2. Rutherford category 4-5
3. No acceptable options for re-vascularisation as confirmed by angiographic imaging results or by color flow duplex ultrasound obtained within 6 months prior screening visit and signed approval of vascular surgeon.
4. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.

Exclusion Criteria:

1. Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
2. Poorly controlled diabetes mellitus (HbA1c \> 9%)
3. Wounds with severity greater than Grade 2 on the Wagner Scale
4. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina pectoris - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged
5. ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment. Patients with severe congestive heart failure (i.e. NYHA Stage IV)
6. In the opinion of the investigator, the patient is unsuitable for cellular therapy.
Pharmacist Intervention to Improve Smoking Cessation

The goal of this study is to assess the effectiveness of a remote pharmacist intervention to help smokers quit.

The main questions it aims to answer are:

* Will smokers being screened for lung cancer with low-radiation-level chest computed tomography (CT) be willing to participate in this study and talk to the pharmacist about smoking cessation?
* Will those in the intervention group be more likely to report smoking cessation than those in the control group.

Participants in the intervention group will be asked to complete a baseline survey; speak with a pharmacist via phone call at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks; and complete an exit survey.

Participants in the control group will be asked to complete a baseline survey and an exit survey.


Eligibility Criteria:
Inclusion Criteria:

* Current smoker
* Current patient in the Lung Cancer Screening Program

Exclusion Criteria:

* Unable to speak/read English
* Unable to provide their own written informed consent
Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens

The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:

- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.

Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes.


Eligibility Criteria:
Inclusion criteria:

- Individuals who present with the onset of febrile neutropenia and at the same time present colonization with an ESBL-producing pathogen (identified through positive routine rectal swabs and/or positive culture of clinical specimen) or risk of infection with an ESBL-producing pathogen (use of 3rd/4th gen cephalosporin or piperacillin/tazobactam for at least 48 hours in the last 30 days).

Exclusion Criteria:

* Patients known to be colonized with carbapenem-resistant or CEF/TAZ-resistant pathogens
* Patients with previous use of carbapenems for at least 48h in the past 30 days are also excluded due to risk of resistance to the study drugs.
* Growth of a pathogen resistant to either study drug in a relevant clinical specimen during the intervention phase will be followed by adjustment of therapy according to local protocol, unblinding, and exclusion from the study.
* Patients that have received less than 72h of either study drug will also be excluded from the final analyses.
Evaluation of Adjunctive Injectable PRF Therapy Used in Conjunction With Scaling and Root Planning

Clinical evaluation of local administration of injectable PRF (injectable platelet-rich fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15 periodontal patients will receive a through traditional mechanical treatment (scaling and root planing). Each patient will receive subgingival i-PRF injected in half mouth and the opposite side will be injected with saline, immediately after the deep scaling session.

The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design. The injected half mouth (study group) for each patient will be allocated randomly. The opposite side will be injected with saline (control group). Clinical parameters will be evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients are in general good health.
* Patients are from both gender and are adult.
* A sign informed consent from participation and permission to use obtained data for research purposes.
* They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
* Presence of bilateral periodontal pockets (≥5 mm) on the minimum of 2 teeth in each side.

Exclusion Criteria:

* Patients less than 18 years' old
* Immunosuppressive systemic diseases (like cancer, AIDS, diabetes...)
* clotting and Hematological disorders
* Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use
* The teeth with poor bad filling and poorly fitted restorations
The Effects of Baduanjin Qigong Exercise on Ankylosing Spondylitis: A Randomized Controlled Study

The aim of this study is to examine the effectiveness of 12-week Baduanjin qigong exercises in patients with ankylosing spondylitis. 59 volunteer individuals, ages 18-64, will be included in the study. They will be randomly divided into two groups (the intervention and the control). The intervention group will perform a qigong exercise program online (via Zoom video conference) for 12 weeks under the supervision of two physiotherapists. The qigong exercise program had previously been videotaped by the researchers. The control group will perform the home exercise program at home for 12 weeks.

This study will be conducted to examine the effect of Baduanjin qigong exercises on patients with ankylosing spondylitis. 29 individuals with ankylosing spondylitis (the intervention group) and 30 healthy individuals (the control group), totaling 59 volunteer individuals ages 18-64, will be included in the study.

The intervention group will perform a qigong exercise program online (via Zoom video conference) for 12 weeks under the supervision of two physiotherapists. The qigong exercise program had previously been videotaped by the researchers. The control group will perform the home exercise program at home for 12 weeks. The intervention group will perform Qigong online exercise program, and the control group will perform home exercises for 45 minutes twice a week for 12 weeks.

In this study the Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index, Chest Expansion Measurement, The Pittsburgh Sleep Quality Index, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, and Ankylosing Spondylitis Quality of Life Questionnaire will be applied before and after the 12-week exercise program in the evaluation of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ankylosing spondylitis diagnosis

Exclusion Criteria:

* Patients with another rheumatological diseases or orthopedic, neurological, psychiatric, cardiovascular, oncological comorbidities
Hidradenitis Suppurativa Phase 2b Study of Izokibep

Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS).

This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.


Eligibility Criteria:
Inclusion Criteria:

General

* Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* 18 years to 75 years of age

Type of Subject and Disease Characteristics

* Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug.
* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III.
* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization.
* Subject must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS.
* Must agree to use daily over-the-counter topical antiseptics.
* Subject must be willing to complete a daily skin pain diary for at least 3 days prior to Day 1 visit.

Exclusion Criteria:

Medical Conditions

* Draining fistula count of \> 20.
* Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization.
* Other active skin disease or condition that could interfere with study assessments.
* Chronic pain not associated with HS.
* Uncontrolled, clinically significant system disease.
* History of demyelinating disease or neurological symptoms suggestive of demyelinating disease.
* Malignancy within 5 years.
* The subject is at risk of self-harm or harm to others.
* Active infection or history of certain infections.
* Tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening (Exception: documented evidence of completed treatment and clinically resolved).
* Known history of human immunodeficiency virus (HIV).

Other protocol defined inclusion/exclusion criteria may apply.
Hospital Foodservice, Patient Satisfaction, and Malnutrition Risk

Malnutrition is the body's inability to absorb necessary nutrients, often due to disease, hunger, aging, or other factors. The European Society for Clinical Nutrition and Metabolism (ESPEN) focuses on the malnutrition aspect \[1,2\]. Unidentified or unmonitored malnutrition before hospitalization, complications affecting eating, patient inability to eat regularly due to exams/treatments, delayed meal times, psychological factors, hospital stay duration, lack of nutrition awareness, prejudices against hospital meals, etc., can lead to hospital malnutrition. Patient-related issues and lack of dietitian referrals may contribute, with food service problems being a key factor in nutritional decline \[3,4\]. The critical factors affecting the patient's food appreciation include the appearance, presentation, taste, consistency, texture, and temperature. In cases where patient expectations and satisfaction are not met, a decrease in food consumption and an increase in the amount of leftovers are observed. It has been observed that if the organoleptic properties and presentation style of the food offered to the patient are good, the patients evaluate the food as high quality, and their satisfaction with the food increases \[5\]. As a result, not being able to consume food due to lack of meal satisfaction means that the energy and elements that the patient needs are not taken into the body, which increases the patient's risk of malnutrition \[4\]. Effective hospital meal provision is crucial in preventing malnutrition, as emphasized by ESPEN. One of the most essential duties of the dietitian is to supervise every stage of food services to ensure the consumption of foods suitable for medical nutrition treatment of the hospitalized patient \[6,7\].

This study aimed to determine the role and effect of hospital food services on inpatient malnutrition. For this purpose, NRS-2002 screening was performed on 310 inpatients within three days after admission. NRS-2002 is a comprehensive screening test that the ESPEN recommends for hospitalized patients. Along with the second NRS-2002 screening, a food service satisfaction survey was administered to patients. The results of both NRS-2002 screening and satisfaction surveys were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* volunteers patients
* Patients who were hospitalized for at least seven days

Exclusion Criteria:

* Patients with a hospital stay of less than seven days,
* receiving oral intake restrictive treatment,
* patients in the terminal phase,
* patients under 18 years of ages,
* patients over 65 years of ages.
Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and can result in patient harm. In order to reduce risk, anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and doing a physical exam, which can aid in predicting which airways may be difficult to manage. The "gold standard" for management of the anticipated difficult airway is to perform an awake flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This affords added safety because the airway remains patent and the patient breaths spontaneously until a tracheal tube is secured, at which point general anesthesia can be induced.

Recently, authors have advocated for alternative methods of management of the predicted difficult airway, most commonly by using a video laryngoscope to perform the awake intubation. A video laryngoscope provides an indirect view of the larynx using a camera at the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency compared to flexible bronchoscopy.

Previous studies that have shown successful awake intubation with video laryngoscopy in the predicted difficult airway have not included patients with head and neck pathology, including malignancies or a history of head and neck surgery or radiation. In this study, the study team will perform video laryngoscopy in patients with head and neck pathology who require awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of the larynx with video laryngoscopy in some patients with head and neck pathology. If there is a significant incidence of difficult video laryngoscopy in this patient population, it will reinforce that anesthesiologists need to continue to learn and maintain skills in bronchoscopic intubation.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Presence of oral, pharyngeal or laryngeal mass or history of surgery or radiation for head and neck cancer
* Requiring awake flexible bronchoscopic intubation for surgery
* Willing and able to provide informed consent

Exclusion Criteria:

* Emergency Procedure
* Presence of one or more loose teeth
A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* Rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987 American College of Rheumatology criteria
* Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept, infliximab, golimumab, or certolizumab)
* Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled, provided their most recent course of RTX occurred over 6 months but no more than 9 months prior to baseline. The RTX dosage must have been two 1000 mg infusions per course administered at the standard approved rate
* Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8 weeks immediately prior to baseline

Key Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following baseline
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Functional class IV as defined by American College of Rheumatology (ACR) criteria
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
* Previous serious infusion reaction to any prior biologic therapy
* Known active current or history of recurrent infection
* Evidence of chronic hepatitis B or C infection
* Pregnant or lactating women
* Body weight of \> 150 kg
Salmeterol Effect on Exercise Performance

The purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Age 18-40
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Active smoker currently or within the past 5 years
* Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
* Chronic or acute illness deemed by the responsible study physician to affect the test parameters
* Deviation from the study protocol
* Lean mass index \>21 kg/m²
* Pregnancy
* Smoker
* Blood donation during the past 3 months
Knee Prosthetic Joint Infection Antibiotic Elution

Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of standard of care in the management of prosthetic joint infection. Secondary outcomes including post-operative complications, re-operation rates, and re-admission rates will also be compared.

The current study aims to assess the surgical and patient-reported outcomes and in vivo antibiotic elution profile of the management of total knee arthroplasty (TKA) prosthetic joint infection (PJI). Within the standard of care, TKA PJI is treated via a resection arthroplasty and antibiotic cement spacer placement. Patients will be enrolled if they are undergoing surgical management for a chronic TKA PJI and will receive surgical treatment according to the standard of care. In the post-operative period, patients will be monitored for surgical and patient-reported outcomes including re-operation rate, pain scores, complication rates, and re-infection rates. Synovial fluid obtained from intra-articular postoperative drains and at postoperative knee aspirations during reimplantation evaluations will also be utilized for antibiotic concentration quantification via mass spectrometry, if sufficient specimen is available. Patient who undergo surgical management for their chronic TKA PJI will then have their measured antibiotic elution concentrations compared. The study hypothesizes that patients undergoing treatment of a PJI with antibiotic spacer + antibiotic cement spacer will have better surgical and patient-related outcomes with higher antibiotic elution concentrations. These improved outcomes would include lower re-operation rates, lower pain scores, lower wound healing complications, and higher rates of second stage re-implantation observed in patients with higher antibiotic elution concentrations.

Specific aims:

1. To evaluate the antibiotic elution profile and post-operative intra-synovial concentrations in the treatment of chronic PJI after TKA.
2. To evaluate surgical and patient-related outcomes in chronic TKA PJI patients following implant resection and knee spacer placement, including amount of post-operative drain output, wound healing complications, 30- and 90-day risk of re-operation, pain scores, and rate of second stage re-implantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for treatment of a total knee arthroplasty prosthetic joint infection
* Patients greater than 18 years of age
* Patients able to provide informed consent

Exclusion Criteria:

* Prior history of ipsilateral or contralateral prosthetic joint infection warranting operative management
* Patients less than 18 years of age
* Patients unable to provide informed consent.
Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells

Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility.

Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal stem cells are combined, and they showed good biological safety.

Eligibility Criteria:
Inclusion Criteria:

* Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant
* Hysteroscopy examination confirmed intrauterine adhesions
* Sign a consent form
* Follow the test plan and follow-up process

Exclusion Criteria:

* have hysteroscopic contraindications
* Chromosome karyotype abnormalities
* Congenital uterine malformations
* Severe adenomyosis
* Contraindications to estradiol treatment
* Medical history of pelvic tumors or receiving pelvic radiotherapy