cyrilzakka/clinical-trials huggingface dataset:
IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes

This study (IEDAL study) intends to prospectively enroll more than 6800 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 25 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.

A multicenter, prospective, double-blind, randomized controlled trial will be conducted (IDEAL study). Patients who are scheduled to undergo cranial CT angiography (CTA) scanning will be randomly divided into two groups with a ratio of 1:1, one of the group will be assigned to True-AI aided intracranial aneurysms diagnosis strategy (True-AI group) and the other will be assigned to Sham-AI aided intracranial aneurysms diagnosis strategy (Sham-AI group, which has a sensitivity close to 0% and a similar specificity to True-AI). The primary outcomes are diagnostic sensitivity and specificity of detecting aneurysms. Secondary endpoints include other diagnostic performance indexes for intracranial aneurysms; diagnostic performances for other intracranial lesions for intracranial arterial stenosis, occlusion, and intracranial tumors; detection rates of intracranial lesions according to Radiology Reports; workload of head CTA interpretation; resource use; treatment-related indexes during patient follow-up (e.g. clinical follow-up, hospitalization, rate of patients undergoing DSA); life quality; outcomes of aneurysm-related events; repeat head CTA or MRA at 12-month follow; cost-effectiveness analysis between intervention and control arm to evaluate the short- and longterm influence of AI system to the routine practice and patients' prognosis and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the outpatient setting who are scheduled to undergo head CTA scanning in 25 hospitals in more than 10 provinces in China.

Exclusion Criteria:

* Age under 18 years.
* Patients with contraindications to CTA.
* Modified Rankin Scale (mRS) score \> 3.
* Refuse to sign informed consent.
* Participation in other clinical studies of intracranial aneurysms.
* Patients with failed head CTA scanning or incomplete image data, or poor image quality.
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.

This study tests the safety and effectiveness of the experimental drug, tipifarnib in older patients who have acute myeloid leukemia (AML). The purpose of this study is to test if tipifarnib can make patients with leukemia live longer. In this study, half the patients will receive tipifarnib and half of the patients will receive the standard treatment. The standard treatment will help to control the symptoms of AML and may include hydroxyurea to lower levels of circulating leukemia cells. Tipifarnib or the standard treatment will be given until the patient's leukemia gets better, or until they experience unacceptable side effects, or until the patient or study doctor decide to stop the study medication. Patients assigned to tipifarnib will be given tipifarnib tablets. Patients should take 6 tablets with food in the morning and 6 tablets with food in the evening, for 21 days in a row. Patients will not take tipifarnib for the next 7 days. This 28 day period is called a cycle. The rest period may be extended beyond 7 days depending on how well the patients tolerate the treatment. Patients will return to the study clinic every week and to visit their study doctor at least every two weeks. A blood draw for routine tests will be done every week. Depending on how your disease is doing, a bone marrow aspiration may be done at the end of every cycle. When patients finish treatment with the study medication, or if they leave the study early, they will be asked to see your doctor for one last visit. Routine laboratory tests will be done. After this visit the study doctor will continue to check with patients to see how they are doing and if they have started a new treatment for leukemia. This check will be made every 30 days and may be made by phone to the patient or to their health care provider. Tipifarnib; six 100 mg in a film coated, compressed tablets are given orally twice a day at for 21 consecutive days on a 28-day cycle schedule.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or re-lapsing AML
* Patient not medically fit for combination induction chemotherapy
* Pathologic confirmation of AML (= or \> 20% bone marrow leukemic blasts)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

Exclusion Criteria:

* Previous cytotoxic or biologic treatment for AML
* Acute promyelocytic leukemia (APL)
* Central nervous system leukemia
* Uncontrolled systemic infection
* Uncompensated disseminated intravascular coagulation
* Symptomatic neuropathy of grade 2 or worse
* Known allergy to imidazole drugs.
Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

This is a single-center, observational study of Tolsura PK sampling in lung transplant recipients

Patients who are receiving Tolsura as part of their clinical care will be asked to enroll and EMR data and excess biological samples will be collected

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* hospitalized at UPMC
* placed on Tolsura prophylactically by clinical team
* patients who have had or will have a lung transplant.

Exclusion Criteria:

* redo lung transplant
* recipient with dual liver-lung transplant
* patients with previous history of SOT
* including other organ transplantation
* patients with known pre-transplant colonization with moulds resistant to azoles
* patients with intra-transplant positive cultures for moulds in either transplant recipient or his/her donor
* patients with a history of hypersensitivity reaction to an azole agent
* patients who are kept NPO (nothing by mouth, including meds)
* recipients or donor with HepC PCR positive
Topical Silver for Prevention of Wound Infection After Cesarean Delivery

A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

* Incision other than pfannenstiel
* Silver allergy
* Inability to provide informed consent
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery

The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.


Eligibility Criteria:
Inclusion Criteria:

* Children \< 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass.
* Body weight \< 10 kg.
* Expected CPB time \> 90 minutes.

Exclusion Criteria:

* Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases \> normal interval for the patient´s age), gestational age \< 34 weeks.
Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures

The purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade.

The study population will be patient who have been diagnosed with an intertrochanteric hip fracture.

Hypothesis: Our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw

Hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050.

Surgical treatment is recognized as the best option in these patients because it allows early rehabilitation and decreases mortality and complications.

Currently, the fixation with a cephalomedullary nail is the most commonly used treatment, since it has some mechanical advantages compared to other fixation methods and achieves adequate stability allowing early weight bearing and rehabilitation with low failure rates.

Changes in the design of these implants have tried to reduce the failure rate. The main change has been the introduction of the helical blade for cephalic fixation, instead of a lag screw. The concept behind this modification is that the blade would have greater fixation to the bone and less risk of cut out, because it is supposed to compact the bone around the helical blade instead of removing it.

In spite of some biomechanical studies in cadaveric or artificial models validating this biomechanical advantage, clinical series have shown controversial results. Recently, retrospective clinical studies have shown similar results with the use of the helical blade, and even some studies have shown a higher failure rate compared to the sliding screw.

Currently there is no prospective evidence regarding the failure rate of these two fixation methods. Our objective is to contribute with solid evidence to solve this answer. That is why we have designed a prospective randomized study with strict inclusion criteria, follow up and radiographic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Low Energy Mechanism
* Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)

Exclusion Criteria:

* Medical contraindication to surgery
* A fracture due to malignancy
* Peri implant fractures
* Inability to walk before the fracture
* An inability to comply with rehabilitation
* Non-ambulatory pre-fracture
Total Lifestyle Reconstruction for Body Weight Control and Maintenance

Obesity stands as a significant health concern of the 21st century. The prevalence of obesity is steadily rising worldwide, and Taiwan is no exception, with nearly four to five out of ten individuals facing issues of overweight or obesity. Additionally, approximately 1.5% of adults suffer from morbid obesity. Presently, lifestyle interventions focusing on body control have shown limited success in maintaining an ideal weight and body composition, and they are predominantly applied within clinical settings for managing morbidly obese patients.

In response to the transformations brought about by the 3C era in connecting with the public, an effective online intervention approach holds promising potential but still requires development and validation. This project endeavors to revolve around "cultivating a healthy lifestyle" by creating educational materials on weight reduction. These materials will encompass various aspects such as dietary habits, physical activity, and daily routines, all designed to impart online lifestyle education. To facilitate the intervention, the investigators plan to employ the application "Cofit" developed by the Cofit Healthcare Inc., targeting individuals with weight reduction needs. Furthermore, the investigators aim to collect research data for the analysis of intervention effectiveness.

Over a three to six-month intervention period, the research participants will receive multifaceted lifestyle education through the online app. Certified nutritionists, trained under the program, will interact with the participants online, guiding them to make changes in their diet, physical activity, and daily routines. The ultimate goal is to help the participants achieve effective weight reduction and maintain a healthy body weight in the long term.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 24 and 35

Exclusion Criteria:

* cancer
* hospitalization
* pregnancy
* depression
* currently taking weight loss drugs
* unwilling to give up meal replacement for weight loss
* unable to cooperate with the data collection and intervention guide of this study
* stage III kidney disease or above
* diabetes
* taking medication
* participation in previous weight loss courses of Qunjian Technology Company
Study of the Effects of Temperature on Metabolism in Human Muscle

This study will examine the role of temperature in changing energy metabolism in human muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide information about how parts of muscle operate during exercise.

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). In this study, MRI will be used to measure the temperature and energy level of specific muscles during rest and exercise. In addition, the muscles being tested will be heated and cooled to see if temperature directly affects levels of energy in muscle.

This study will examine the role of temperature in modulating aspects of energy metabolism in human skeletal muscle. Tests will be conducted at rest and during concentric dorsiflexion exercise of the Tibialis anterior (TA) muscle using an existing custom-designed dynamometer in conjunction with mild local heating and cooling. Magnetic resonance spectroscopy (MRS), performed in a 4-tesla whole-body NMR system, will be used to non-invasively measure muscle temperature and energy-state. Specifically these tests will assess the extent to which temperature changes occur during aerobic exercise and how small temperature changes affect mitochondrial function in-vivo.

Eligibility Criteria:
Ages 18 to 50.

Male and female subjects.

Capable of giving informed consent.

Healthy normal volunteers.

No cardiac pacemaker of implantable defibrillator.

No aneurysm clip.

No neural stimulator (e.g. TENS-unit).

No ear implant of any type.

No metal in the eye (e.g. from machining).

No implanted device (e.g. insulin pump, drug infusion device).

No metallic foreign body, shrapnel, or bullet.
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist

This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist. Approximately 26 Japanese subjects will be recruited to receive 22 completed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12 - 75 yrs
2. Documented physician-diagnosed asthma
3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of their Predicted Normal Value (PNV)
5. Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

Exclusion Criteria:

1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant of breastfeeding
5. History or cancer
6. Current tobacco smoking or a history or tobacco smoking for ≥10 pack-years
7. Previous receipt of tralokinumab
Biosafety of Musical Instruments in the ICU

This study investigates the efficacy of the institutional disinfection protocol for musical instruments in the ICU of the music therapy service of the University Hospital Fundación Santa Fe de Bogotá (FSFB), Colombia.

Introduction: Nosocomial infections can negatively affect the recovery and well-being of patients. Music therapy is a profession that uses music and sounds to improve the health, well-being and quality of life of patients. Musical instruments are regularly used in music therapy sessions, such as the string or percussion instruments, among others. Since the musical instruments are also played and handled by the patients, the question arises if the disinfection and cleaning protocol for musical instruments of the music therapy service at the University Hospital Fundación Santa Fe de Bogotá (FSFB) is effective and safe.

Objectives: To establish the effectiveness and impact of the disinfection protocol of musical instruments used by the music therapy service in the ICUs of the FSFB.

Methodology: This is a study carried out in 2 phases. The first phase corresponds to an experimental design in which the presence of microbiological viability will be evaluated through ATP bioluminescence tests and cultures before and after the application of the disinfection and cleaning protocol in a controlled environment. The second phase corresponds to a prospective cohort study in which music therapy patients will be followed up ver a period of two months, determining the impact of the disinfection and cleaning protocol.

Analysis: A descriptive analysis will be applied where the qualitative variables will be presented in their absolute and relative frequencies. For the quantitative variables, the Kolgomorov-Smirnov test will be applied to define the distribution of the data and, according to these, corresponding descriptive statistics will be carried out. In addition, a bivariate analysis will be performed between the outcome variable (infection or not) versus the exposure variables with a regression-type confounding analysis (logistic - binary as applicable) to identify co-variability phenomena.

Expected results: This study seeks to improve patient safety, raise awareness in the music therapy community about the importance of proper cleaning of their work tools, and promote inter- and transdisciplinary knowledge between the fields of music therapy, critical medicine and epidemiology.

Eligibility Criteria:
Inclusion Criteria:

* Being hospitalized in the and having participated in a music therapy service from July 1st to August 31st 2023.

Exclusion Criteria:

* Not having participated in a music therapy service during the same time frame.
The Efficacy and Safety of Ta1 for Sepsis

The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis

Our previous study reported that the 7-day treatment of Ta 1 demonstrated positive active effect as to the 28-day all-cause mortality and the augmentation of mHLA-DR (monocyte Human Leukocyte Antigen DR) at the secondary endpoint. Therefore, we intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤85;
2. Signed informed consent signed;
3. Diagnosed as a sepsis according to the sepsis diagnosis criteria in "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016": at least one acute severe organ dysfunction related to sepsis, and total SOFA scores ≥2;
4. Infected focus are confirmed or suspected and satisfy at least one of the followings:

   1. pathogenic microbes grow in blood or at aseptic locations
   2. presence of abscess or partially-infected tissues
   3. suspected infection identified by at least one of the following evidences:

      * leukocytes at normal aseptic locations
      * organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage)
      * Imaging evidence of pneumonia accompanied by purulent secretion
      * Related syndromes with high infection risk (cholangitis for example)

Exclusion Criteria:

1. History of organ or bone marrow transplantation;
2. Acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis;
3. Under pregnancy or in suckling period;
4. Presence of hematologic malignancies;
5. The patient has received radiotherapy or chemotherapy within the past 30 days;
6. The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment;
7. The patient has in the past 30 days received immunosuppressive drugs (tripterygium wilfordii, CellCept, cyclophosphamide, FK506, etc.) or received continuous treatment with prednisolone \>10 mg/day (or the same dose of other hormones);
8. The patient could die of an underlying disease within 28 days or is in end-stage;
9. The patient has undergone CPR in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (GCS score ≤ 8);
10. The patient has in the past 30 days used thymosin or undergone certain clinical drug or instrument trials which could affect immunity (such as Xuebijing, ulinastatin and CRRT);
11. The patient has a medical history of allergy or intolerance to thymalfasin;
12. The source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.