cyrilzakka/clinical-trials huggingface dataset:
A Study of Contralateral Limb Block

This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.


Eligibility Criteria:
Inclusion Criteria:

* Lower extremity amputation performed more than 12 months before study enrollment
* PLP/RLP in affected amputated limb \> 4 on NRS26
* Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
* Willingness to undergo image guided diagnostic nerve block

Exclusion Criteria:

* Refusal / inability to participate or provide consent
* Contraindications to diagnostic nerve block
* Non-neurogenic source of PLP/RLP
* Current opioid use \> 50 morphine milligram equivalents per day
* Any interventional pain treatment in the residual limb within the last 30 days
* Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
* Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

The primary goal of the study is to assess ultrasonographic Power Doppler signals after ultrasound-guided puncture and lavage of rotator cuff calcific tendinitis of the shoulder. Secondary outcomes are sonographic features like the course of residual calcific material and the course of tendon healing als well as the clinical symptoms of the patient.

In our study we investigate the intensity of the power doppler signal after ultrasound-guided puncture and lavage (UGPL) of the rotator cuff calcific tendinitis. We assume that UGPL will lead to intratendinous neovascularisation and that the amount of retrieved calcific material is associated with the PDUS signal. The measurement of the signal will be performed in pre determined time slot for 12 months. Additional we study the correlation between the PDUS signal and the clinical symptoms of the patient and the healing process.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and older
* Pain in the deltoid region worsening with activities above shoulder level and/or at night with a calcific deposit
* Ultrasound evaluation of the calcific deposit with type I or II characteristics, a solitary conformation, a minimum size of 1.0 x 0.5 x 0.4cm (length x width x depth) and without clear signs of resorption (PDUS grade 0 - I°, see study procedure).
* In case of multiple calcific deposits, it has to be warranted that the other deposits are smaller than the minimum size of 1.0 x 0.5 x 0.4cm and with no signs of PDUS signals.
* Qualification for more intensive treatment on account of no clinical improvement after a minimum of 3 months with conservative treatment (physical therapy and oral anti-inflammatory drugs).
* able to understand the content of the patient information / consent form in German and give consent to take part in the project

Exclusion Criteria:

* Previous UGPL or surgery of the affected shoulder
* Treatment with subacromial injection (SAI) or ESWT in the three months before inclusion
* Other causes of shoulder complaints (e.g. rotator cuff tear, frozen shoulder, inflammatory arthritis, bursitis, ...)
* Intervention failure (no retrieval of calcific material, leakage of the injected saline, disruption of the calcific rim or distribution of calcific material)
* Patients with a language barrier hindering questionnaire completion
* Pregnancy
Evaluation of the Signa Excite 3.0 T MRI Excite for Detection and Characterization of Liver Lesions

Primary Objective:

1. To compare the efficacy of 1.5T vs. 3T T1 and T2-weighted MR images sequences for the detection and evaluation of liver lesions.

Magnetic resonance imaging is taken with scanners at different magnetic field strength. The current practice at UTMDACC is to perform these exams at 1.5 Tesla. Tesla is the unit of strength of the magnetic field. This study will compare the images taken at the standard 1.5 Tesla (T) magnetic field with those at the newer 3.0T magnetic field.

You are already scheduled to receive a standard 1.5 T MR of the liver area as requested by your doctor. As part of this study, you will then be asked to return on a separate date to have a similar exam performed with the Signal 3.0T Excite MR scanner. You will return within a two week period from the date of your first MRI examination. The examination will be performed in a machine that looks similar to the 1.5T scanner. It will also take about the same amount of time as the examination at 1.5T.

The images taken by both scanners will be evaluated and compared. After you have had the second scan, your participation in this study will be over. If there are new findings identified with the new scan your doctor will be notified.

This is an investigational study. The 3.0T scan will be performed free of charge. A total of 20 patients will take part in this study All will be enrolled at UTMDACC.

This protocol is partially funded by a research grant from General Electric Medical Systems (GEMS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a liver lesion larger than 1cm detected by a prior imaging modality.
2. Patients have been scheduled and are eligible for an MRI of the abdomen or MRI of the liver or MRI of the kidney examination.

Exclusion Criteria:

1) Patients who are unable to cooperate with breath hold.
Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans

The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18+.
* Clinical diagnosis of acanthosis nigricans.
* Available and willing to comply with study instructions and attend all study visits.
* Able and willing to provide written and verbal informed consent.

Exclusion Criteria:

* Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
* Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
* Pregnant, lactating, or is planning to become pregnant during the study.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
* Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
* Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
* Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
* Erosions, ulcers, or other skin lesions within or closely neighboring the AN lesion application site.
* Hypersensitivity reactions such as anaphylaxis or angioedema to sirolimus or any component of sirolimus 0.2% topical gel (HYFTOR).
* Dyslipidemia (cholesterol level \>300mg/dL or \>7.75mmol/L, triglyceride level \>300 mg/dL or \>3.42 mmol/L).
* Subject cannot agree to take appropriate contraception for the duration of the study and 12 weeks after the final dose.
* Exclusions apply to those who have used the following topical treatments to treat AN: retinoids, hydroquinones, corticosteroids, or other depigmenting agents within one month prior to the study, or oral retinoids within six months prior to the study, or medications with mammalian target of rapamycin(mTOR) inhibitory action within 12 months prior to the first visit.
* Subjects with a malignant tumor
AI in Respiratory Disease Prevention, Diagnosis, and Triage

This study will evaluate the impact of using the GPT-4o compared to traditional online tools in the field of respiratory disease prevention, focusing on the dissemination of knowledge and behavior changes among the general public. We will explore the effectiveness of GPT-4o in enhancing public awareness and management capabilities regarding respiratory diseases and promoting appropriate preventive behaviors.

Artificial intelligence (AI) technologies, particularly advanced large language models like GPT-4o developed by OpenAI, hold immense potential in enhancing public health education and preventive behaviors. Although GPT-4o was not specifically designed for respiratory disease prevention, it has shown promising prospects in numerous healthcare-related applications, such as providing health information, responding to public inquiries, and supporting health education efforts. However, its effectiveness in improving public awareness and management capabilities regarding respiratory diseases remains to be further explored.

Understanding and managing respiratory diseases involve complex processes, including symptom recognition, application of preventive knowledge, and informed decision-making. Integrating AI tools like GPT-4o into public health education could potentially enhance knowledge dissemination, reduce misinformation, and encourage appropriate preventive behaviors among the general population. Nevertheless, GPT-4o has not been specifically validated for respiratory disease prevention and carries the risk of generating misleading or inaccurate information, which could confuse users. Improper use of such tools may fail to raise awareness and could even lead to counterproductive behaviors. Therefore, studying how large language models like GPT-4o can effectively support public education and behavior change in this context is of critical importance.

In this study, participants will be randomly divided into two groups: one group will have access to Fine-turned GPT-4o, while the other will rely solely on traditional online tools. They will be presented with scenarios related to respiratory diseases and asked to explain their identification of high-risk factors, understanding of diagnoses, and proposed triage actions for each scenario. Each scenario was developed by a panel of three experts in respiratory health, who also established standardized answers. Responses will be evaluated by two independent groups of reviewers unaware of the participants' group assignments. These experts independently created initial scoring criteria and resolved discrepancies through multiple rounds of discussion to ensure consistency and accuracy.

Eligibility Criteria:
Inclusion Criteria:

* No medical background
* Aged from 18 to 75 years old

Exclusion Criteria:

* Had a medical background
* Exceeds the age criteria
* Failed to comply with the survey requirements
The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients

To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment.

To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor.

Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment. Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status of grade I-II
* Cardiac function classification by NYHA of grade I
* without high risk factors according to the revised Lee cardiac risk index:

  1. High-risk type of surgery
  2. Ischemic heart disease
  3. History of congestive heart failure
  4. History of cerebrovascular disease
  5. Insulin therapy for diabetes
  6. Preoperative serum creatinine \> 2.0 mg/dl
* undergoing gastrointestinal tumor surgery

Exclusion Criteria:

* Patients under 18 years or above 55 years
* patients with severe aortic regurgitation
* patients with permanent cardiac arrhythmias
* patients with intra-aortic balloon pump
* patients with severe pulmonary disease
* patients with hepatic or renal dysfunction
* patients undergoing emergency surgery
A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty

Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods.


Eligibility Criteria:
Inclusion Criteria:

* Hip replacement surgery is indicated
* ASA Class II - Class III
* No history of analgesic or local anesthetic allergy
* No history of alcohol abuse or narcotic drug abuse
* Patients and their families have given informed consent and signed the informed consent form

Exclusion Criteria:

* Patient or family refusal to participate in the study
* Severe coagulation abnormalities
* Local anesthetic allergy
* Severe psychiatric illness or other communication disorder
* There is an infection at the puncture site
* History of neurological disease such as Guillain-Barré syndrome
* Delay in awakening post-surgery for more than 60 min,
* Post-surgical use of an analgesic pump
* Inability to follow-up at the required time points.
A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Extensive Stage Small Cell Lung Cancer

The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve SCLC
* DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive is defined as staining in ≥75% of tumor cells.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Minimum life expectancy of at least 12 weeks.
* Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug.
* Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb, total bilirubin, ALT, AST and GFR)
* Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids
* Use of effective contraception method during and for 1 year following study drug dosing if female of childbearing potential or sexually active male

Exclusion Criteria:

* Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) SCLC.
* Any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study.
* Documented history of a cerebral vascular, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
* Recent or ongoing serious infection.
* Women who are pregnant or breastfeeding.
* History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.
* Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation
Association of Frailty and Delirium in Elderly Hip Fracture Patients

Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. The purpose of this study is to determine whether preoperative frailty can be used as a diagnostic and predictive factor for postoperative delirium in elderly patients with hip fracture.

Frailty index (FI) is a reliable method to determine the assessment of frailty in elderly patients. Multiple prospective cohort studies have shown that frailty can be used as a marker for risk of adverse outcomes in older adults such as falls, disability, hospitalization, and mortality, and can be used to predict patient clinical outcomes. Whether frailty could be used as a diagnostic and predictive factor for delirium is urgently needed in a large population.

Therefore, this project intends to conduct a prospective cohort study. Patients will be divided into three groups according to frailty index (FI) before surgery, and delirium status will be evaluated by using scales after surgery, so as to explore the diagnostic and predictive value of frailty on POD. Once confirmed, the results of this study will be helpful for the early identification, screening, diagnosis and evaluation of treatment effect of POD. It is of great scientific significance and social benefit to reduce the incidence of POD, improve the prognosis of vulnerable patients and reduce the burden of disease.

Eligibility Criteria:
Inclusion Criteria:

* The subjects were patients with hip fracture;
* Older than 65 years;
* Patients signed informed consent;
* American Society of Anesthesiologist (ASA) Rated I- III;
* The surgery was performed by the same anesthesia and surgical team.

Exclusion Criteria:

* Patients cannot sign the consent form or refuse to participate;
* A history of cognitive impairment;
* Unable to complete the cognitive function test;
* Mental disorder during initial assessment;
* Patients suffering from mental illness or substance use disorder;
* Incomplete or lost data during follow-up.
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury

RCT colloids versus cristalloids only in severe burn victims.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Deep burn injury more than 15% of total body surface area (2nd and 3rd degree burns)
* Informed consent (via deferred consent, if necessary, according to Swiss HMG § 55 and 56).
* Patients or relatives can understand the study information and the provided information in German language

Exclusion criteria:

* Patients expected to succumb within the next 24 to 36 hours, i.e. whole body burn trauma, palliative care situation
* Pregnancy
* No informed consent
* Known allergic reaction to HES
* Patients or patient's relatives, who do not understand the German language and therefore the study information, can not be provided in a legally correct manner.
* Patients with contraindications for balanced 6% HES 130/0.4, i.e. heart failure, pulmonary edema, intracerebral bleeding, acute renal failure, severe hypernatraemia and other severe electrolyte imbalances, severe von-Willebrand Syndrome and acute liver failure (see "Arzneimittelkompendium der Schweiz® - Documed")
FOCUS Guidelines and Adherence to Physical Activity in Ageing Women.

The study aimed at assessing whether the guidelines from the European project FOCUS had an effect on adherence to a physical activity program in older women. The program consisted of two 12-week periods, in which women followed a set of pre-specified exercises (1 hour, twice per week). The first period was supervised by a monitor while the second was autonomous. Support groups, in which the contact between participants was established through information and communication technologies (social-network through the mobile phone), were set up to maintain engagement between participants. Women were randomized to three arms consisting of 2 intervention groups, with and without the FOCUS guidelines, and a sedentary control. Secondary outcomes included a battery of dimensions affecting physical performance, psychological status, and quality of life.

The objectives of the study consisted of assessing i) whether the use of the Guidelines derived from the European project FOCUS had an effect on the adherence to a physical activity (PA) program (primary objective), and ii) the effect of the program, which included 2 h/week of PA, on a group of dimensions related with general health, frailty, psycho-cognitive parameters, and quality of life (QoL) (secondary objectives).

The study comprised 24 weeks in which a group of 90 postmenopausal women were randomised to three arms, two in which participants were performing PA, and one control (no intervention).

The first PA group followed the FOCUS guidelines, in which women received monthly health talks and had an internet mailbox to facilitate contact with health professionals.

The PA program consisted of a twice per week 1-hour session along 24 weeks. This period was divided into two parts, a first supervised phase in which women followed group sessions under direct supervision of a monitor, and a second period in which the groups of women followed the same exercise pattern, but autonomously. A mobile phone support system (social network whatsapp) was used for inter-connection and mutual support during the autonomous period. Assessments were performed at baseline and then at 12 weeks and 24 weeks, representing the completion of the supervised and the autonomous periods, respectively.

Eligibility Criteria:
Inclusion Criteria:

Community living postmenopausal women capable of performing the physical activity program and with ability to sign the informed consent.

Exclusion Criteria:

Physical or psychological deficiencies incapacitating subjects to participate in the established physical program.