cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, Study of BMF-500 in Adults With Acute Leukemia

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral FLT3 inhibitor, in adult patients with acute leukemia.

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral covalent FLT3 inhibitor, in adult patients with acute myeloid leukemia (AML), who may or may not be on Antifungals.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years.
* Individuals with histologically or pathologically confirmed diagnosis of relapsed or refractory AML with documented FLT3 mutation, and/or Individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type FLT3 (including those with MLL1-R and NPM1 mutations).
* ECOG performance status of 0-2.
* Adequate liver and renal function
* Adhere to the CYP3A4 inhibitor concomitant therapy use requirements, as follows:
* Arm A: Participants must not have received a moderate or strong CYP3A4 inhibitor for at least 7 days prior to enrollment and are not anticipated to require such agents in the near term (for at least 4 weeks).
* Arm B: Participants must have received a necessary azole antifungal(s) that is a strong CYP3A4 inhibitor (excluding other strong CYP3A4 inhibitor\[s\]) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on BMF-500 treatment for at least 4 weeks.
* Arm C: Participants must have received necessary azole antifungal(s) that are moderate CYP3A4 inhibitors (excluding other moderate CYP3A4 inhibitors) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on BMF-500 treatment for at least 4 weeks (Cycle 1).

Key Exclusion Criteria:

* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, history of cerebrovascular accident including transient ischemic attack within 6 months prior to the first dose of the trial intervention.
* WBC count \>50,000/µL (uncontrollable with cytoreductive therapy).
* Women who are pregnant or lactating or plan to become pregnant.
The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus

Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.

This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.

Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?


Eligibility Criteria:
Inclusion Criteria:

* women with a new LSIL diagnosis an HPV positivity on PAP smear

Exclusion Criteria:

* women over 65
* immunocompromised patients (because of disease or drugs)
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors

Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a ligand (EC20) designed to bind to the folate receptor. The study is designed as an open-label, baseline-controlled study.

This is a Phase 2 open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of subjects with pituitary tumors with increased uptake of FolateScan in tumors and correlate the immunohistochemical staining findings with the FolateScan images, in subjects with pituitary tumors.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following eligibility requirements to be enrolled in the study:

1. Subject must be 18 years of age or older.
2. Subject must have a pituitary tumor.
3. Subject must have good kidney function.

3. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

Subjects must be excluded if any of the following conditions are present:

1. Subject is pregnant or breastfeeding.
2. Subject is simultaneously participating in another investigational drug study.
3. Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study.
4. Subject is unable to tolerate conditions for radionuclide imaging.
5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Medical Physics Direct Patient Care for the Improvement of Patient Understanding of Care

This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.

PRIMARY OBJECTIVE:

I. To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.

SECONDARY OBJECTIVE:

II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive printed materials describing the technical aspects of their treatment.

ARM II: Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.

Eligibility Criteria:
Inclusion Criteria:

* Medical physicists will be eligible if they care for patients within the Gershenson Radiation Oncology Center within the Karmanos Cancer Institute and have completed the patient communication training
* Are able to read and write in English
* Are scheduled for curative radiation therapy at the Gershenson Radiation Oncology Center

Exclusion Criteria:

* NONE
Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis

The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of usual clinical practice. Likewise, collect safety data, recording adverse events related to medication.

This is an observacional follow-up study, open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center study in adult participants with moderate to severe atopic dermatitis. A registration can also be made retrospective data from the patient's medical history.

Participants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).

A series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* Patients treated with any systemic therapy (other than topical therapy) according to criteria clinical and routine clinical practice. Therefore, the treatments included will be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib and tralokilumab.
* Patients who grant informed consent.

Exclusion Criteria:

* Patients who do not have the necessary comprehension capacity to understand and sign the informed consent.
* Patients who, according to routine clinical practice, require only topical treatment.
The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery

This study focuses on providing clinical care to patients undergoing VSD drainage surgery for chronic wounds, while also paying attention to the impact of negative emotions such as depression and anxiety, as well as quality of life and social support, on the patients' physical and mental well-being. It observes the influence of psychology on patients.

The chronic, difficult-to-heal wounds not recovering within the expected timeframe not only impact the quality of life for patients and hinder the recovery of the primary condition but also exacerbate their financial and psychological burdens, further affecting the quality of wound healing. The objective of this study is to employ psychological nursing interventions effectively combined with nursing techniques and communication strategies. By listening to patients' fears, anxieties, and tensions, it significantly alleviates their negative emotions, enhances compliance with medical advice, and predicts postoperative complications to mitigate them. Tailored and empathetic care, along with psychological counseling, is provided to expedite wound healing.

Eligibility Criteria:
Inclusion Criteria:

- A mentally healthy, communicative adult. Patients and their families are cooperative, understanding, and supportive of this study.

Adult patients undergoing VSD surgery for chronic wounds.

Exclusion Criteria:

- Patients who are unable to effectively cooperate with nursing questionnaires due to auditory or visual impairments, cognitive impairments, or low levels of cultural literacy.

Patients with poor compliance or those who harbor skepticism and hostility towards this research.
Impact of Videos on Patient Anxiety and Satisfaction

The purpose of this research is to look at how educational videos might affect patient satisfaction and anxiety before Mohs surgery day. Patients will be randomized to either: 1) a group that receives educational videos before the visit in addition to standard-of-care written and verbal instructions OR 2) a group that receives only standard-of-care written and verbal instructions.

The primary objective of this study is to determine if pre-operative videos describing the patient's forthcoming day in the Mohs clinic decrease pre-operative patient anxiety and increase postoperative patient satisfaction, when added to standard of care written and verbal instruction.

Design/Study Type This study will be a randomized control trial in which patients will be randomized to either the intervention (pre-operative Mohs Surgery video viewing) or control (standard of care) group in order to understand the impact of the video on patient anxiety and satisfaction. Patients will be randomized using an Accelerated Biased Coin Design in the statistical program R.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at the University Hospitals Cleveland Medical Center Mohs Clinic to undergo a linear closure on the face.
* Fluent English speakers

Exclusion Criteria:

* Non-fluent English speakers
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction

The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for pain medication after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female patients \>/= 18 years old
* Undergoing Bilateral Mastectomy with immediate reconstruction (BMw/IR)
* Scheduled for surgery at Josie Robertson Surgical Center (JRSC)
* Must be appropriate for an agree to receive a nerve block
* Must be appropriate for randomization
* Able to read and speak English
* Willing and able to provide written informed consent

Exclusion Criteria:

* None applicable, as exclusion occurs prior to consent
The Role of Mitochondrial Respiration in the Cardioprotective Capacity of IPC in Diabetic and Non-diabetic Patients

The overall aim of this study is to examine the role of mitochondrial respiration in human diabetic tissue before and after ischemia. Furthermore we will examine the ability of ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic performance of both non-diabetic and diabetic fibers after ischemia. To increase our understanding on the metabolic changes during ischemia in both non-diabetic and diabetic tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic mitochondrial respiration.

20 diabetic and 20 non-diabetic patients undergoing elective CABG surgery or other heart surgery where extracorporal circulation is used will be included in the study. The patiens will not be given any treatment prior to the operation. During the cardiac surgery a small sample of the heart is routinely removed when the patient is connection to the heart-lung machine. From this tissue sample it is possible to isolate muscle trabeculae which will be used in an atrial strip model and randomized to one of four types of treatment. Simultaneously with the isolation of the trabeculae, a fifth trabecular will be used to assess mitochondrial respiration at baseline. Group 1 will serve as a sham control, group 2 will serve as ischemic control and receive an extended period of hypoxia, Group 3 will be treated with ischemic preconditioning, where short periods of non lethal lack of oxygen will be given directly to the tissue (after removal from the patient) prior to the extended period of hypoxia, Group 4 will receive dimethyl malonate prior to the prolonged hypoxia.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CABG or other surgery where extracorporal circulation will be used.

Exclusion Criteria:

* raise in ischemic markers within 4 weeks
* ejection fraction \<30
* Atrial fibrilation
* Oral opioid treatment
Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients

The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients


Eligibility Criteria:
Inclusion Criteria:

* subjects in need of CT scanning
* subjects who signed up informed consent

Exclusion Criteria:

* Known allergy or hypersensitivity to the study medication, ingredient of the medication, and Iodine type medication
* severe renal insufficiency patients
* severe hypothyroidism
* severe local infection or bacteremia
Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study

Objective: To investigate gender-based differences in outcomes following robotic surgery for rectal cancer.

Methods: A retrospective study was conducted on 155 patients (82 males, 73 females) who underwent robotic surgery for rectal cancer. Demographic, pre-operative, operative, and post-operative data were collected and analyzed.

Pre-operative study:

All patients underwent a standardized pre-operative work-up, which included a physical examination, comprehensive colonoscopy with biopsy, rigid rectoscopy, pelvic magnetic resonance imaging (MRI) scan, computed tomography (CT) of the thorax and abdomen, and measurement of carcinoembryonic antigen (CEA) levels. Tumor staging followed the TNM staging criteria (American Joint Committee on Cancer), with the T and N stages determined by the most advanced findings from any imaging modality

Data collected:

Retrospective evaluation and comparison of demographic characteristics, pre-operative TNM stage, distance from anal verge, tumor size, tumor grade, American Society of Anesthesiologists (ASA) score, and body mass index (BMI) were conducted among both patient groups. Peri-operative and post-operative data, including morbidity and mortality, were assessed, alongside parameters such as distal resection margin (DRM), proximal resection margin (PRM), harvested lymph nodes (HLN), and Clavien-Dindo Classification (CDC) scores. Diagnosis of anastomotic leakage was confirmed by clinical suspicion (e.g., changes in drainage, fever, abdominal pain) and further validated through contrast enema observed during follow-up computed tomography (CT). Hospital stay and readmission rates were monitored for up to 90 days post-surgery.

Post-operative follow-up:

Post-operative outcomes encompassed operative duration, estimated blood loss, time to first flatus passage, duration of liquid diet, and length of hospital stay following surgery. Operative duration comprised the time from initial skin incision to closure, including the time needed for robotic surgery docking and undocking. Upon experiencing initial flatulence, patients transitioned to a liquid diet. Hospital stay duration was measured from the time of surgery to discharge. The overall cost of surgery, including surgical procedures, anesthesia, medications, and post-operative care, was considered in the total expenditure analysis.


Eligibility Criteria:
Inclusion Criteria:

A confirmed histological diagnosis of colorectal malignancy was a prerequisite for enrollment in this study. Additionally, obtaining informed consent from patients for surgical intervention was mandatory.

Exclusion Criteria:

Patients with bleeding of the gastrointestinal tract, inflammatory bowel disease, synchronous tumors, benign conditions, and clinical T4 stage tumors unresponsive to neoadjuvant therapy were excluded from the study.
Hospital Wide Roll-Out of Antimicrobial Stewardship

Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.


Eligibility Criteria:
All patients admitted to the medical/surgical services will be included in statistical analysis of program evaluation. The inclusion/exclusion criteria below, just define who receives the antibiotic stewardship intervention on each service.

Inclusion Criteria:

* admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery
* receiving 3rd or 10th day of treatment with one of the following antibiotics:
* ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin

Exclusion Criteria:

* patient being followed by the infectious diseases consult service
Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits

The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

This proprioceptive deficit is found following various traumas or injuries such as Anterior Cruciate Ligament (ACL) rupture, for example.

The use of joint stabilizers (such as knee braces) will allow an increase in sensory input (particularly at the level of cutaneous mechanoreceptors), and improve the biomechanics of the injured joint.

The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a proprioception deficit of the knee: detection threshold higher than 2.5° on the TTDPM (Threshold to detect passive motion) test
* Patient whose knee measurements are compatible with the sizes of the proprioceptive knee brace
* Patient having signed a free and informed consent form
* Patient affiliated or entitled to a social security plan

Exclusion Criteria:

* Patient with knee pain on walking greater than or equal to 4 out of 10 on a VAS scale.
* Patient in the early phase of acute trauma to the lower limb
* Patient having worn a knee brace in the 48 hours prior to inclusion
* Pregnant women
* Patient presenting one of the contraindications to the use of the knee brace, indicated in the instructions for use
* Patient with a major cognitive impairment incompatible with participation in a clinical trial
* Patient participating in another clinical investigation conducted to establish the conformity of a DM (Medical Device) impacting the judgment criteria
* Vulnerable patient according to article L1121-6 of the public health code, person subject to a judicial protection measure or unable to consent freely
Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams

This study endeavors to implement a brief video-based mindfulness intervention within a clinic setting for women undergoing pelvic examinations, in hopes of reducing state anxiety and pain intensity during pelvic exams and improving overall exam satisfaction and likelihood to return for follow-up exams. This will be a pilot study will take place the University of Texas Southwestern (UTSW) Lowe Foundation Center for Women's Preventative Health Care. There will be a treatment and a control arm, estimated 50 women per group.

Participants will be randomly assigned to either a treatment group or a control group. Treatment group will receive a 5-minute mindful movement video-based intervention before their previously scheduled pelvic exam. Control group will not receive the mindful movement video-based intervention and will instead be given a handout about the benefits of mindfulness to read prior to the pelvic exam. Control group will be given access to the mindfulness intervention via an online link upon completion of participation in the study to ensure they are provided the opportunity to benefit from mindfulness practice.

Participants will be recruited from a group of female patients at the Lowe Foundation Center who have already been scheduled for an upcoming pelvic exam. Therefore the pelvic exam procedure itself is standard of care, the experimental piece is the mindfulness intervention before the pelvic exam - either the video, or the written educational materials depending on whether participants are randomly assigned to the treatment or control group.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age of 18+ years
3. Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.

Exclusion Criteria:

1. Participants who are unable to read, speak, write or understand verbally spoken English
2. Participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention.
3. Participants who are pregnant will be excluded from the study.
4. Individuals presenting to the clinic for an acute pain reason will be excluded from the study.