cyrilzakka/clinical-trials huggingface dataset:
A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate video scale assessments.


Eligibility Criteria:
Inclusion Criteria:

* Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.
* Have a study partner
* Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A

Exclusion Criteria:

* Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study.
* Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study.
* Poor venous access
* Contraindication to PET or MRI imaging
Evaluate the Depth and Duration of Anesthesia

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.


Eligibility Criteria:
Inclusion Criteria:

* Had no known significant diseases
* Normal 12-lead electrocardiogram
* Willing to refrain from using any local topical preparations

Exclusion Criteria:

* Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
* Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
* Had an active dermatological disease of any origin that may have interfered with their ability to participate
Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers

To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.

In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.

Eligibility Criteria:
Inclusion Criteria:

* (1) Healthy infants of ≤ 12 months of age;
* (2) Can provide proof of legal identity;
* (3) Have completed two doses of sIPV vaccination at Beijing Institute;
* (4) Able to provide proof of sIPV vaccination;
* (5) The participant's guardian can understand and agree to sign the informed consent form.

Exclusion Criteria:

* (1) Known severe allergy to vaccines or vaccine components, such as urticaria, dyspnea, angioneurotic edema;
* (2) Received immunoglobulins or other blood products, or plan to receive such treatment during the study;
* (3) Received ≥14 days of immunosuppressive or other immunomodulatory therapy or cytotoxic therapy, or plan to receive such therapy during the study;
* (4) Received another investigational vaccine within 28 days before receiving the study vaccine;
* (5) Received a live attenuated vaccine within 14 days before receiving the trial vaccine;
* (6) Received a subunit or inactivated vaccine within 7 days before receiving the trial vaccine;
* (7) Acute exacerbation of various acute illnesses or chronic diseases within the last 7 days;
* (8) Those who had a fever with an axillary temperature \>37.0°C before receiving the study vaccine;
* (9) Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in the study.
Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases

The objectives were (1) to evaluate the characteristics of the patients referred, and (2) the effect of a community-based Exercise on Prescription program on their physical capacities and their quality of life.

The program consisted in 30 supervised physical activity (PA) group sessions (75 min) over a 4-month period and participant were prescribed the program by their doctors.

The participants had chronic diseases among type 2 diabetes, mental disorders, musculoskeletal disorders, childhood and adult obesity and stabilized cardiovascular diseases.

Tests and questionnaires were completed before and after the program. Physical tests were the 6-minute walk test, the timed up \& go, the 30-s stand up chair, the single leg support test and the back scratch and toe-touch tests. Questionnaires were the self-administered Ricci and Gagnon questionnaire about PA level and the 12-Item Short Form Survey for measuring quality of life.

Personal goal from the participants and medical objective from their doctors were collected before the program.


Eligibility Criteria:
Inclusion Criteria:

* All participant referred to the Exercise on Prescription Program (Caen)

Exclusion Criteria:

* French language not sufficiently read and/or spoken
* Lack of clear information on the study
* Alteration of higher functions or sensory disturbance making understanding and adherence to the research protocol impossible.
Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism

The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder

The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder. Women with hyper- og hypothyroidism are included and undergo usual treatment. Patients are stratified into 10 different groups.

Eligibility Criteria:
Inclusion Criteria:

informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,

Exclusion Criteria:

pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids,
Toward High Fidelity Adaptive Radiotherapy in the Thorax

Daily adaptive radiotherapy with individualized planning margins for thoracic and pelvic cancer patients will increase the potential of reducing dose to OARs, thereby reducing treatment-related toxicities and ultimately providing these patients with a better quality of life. Thus, the overarching objective of this work is to develop a CBCT-guided adaptive workflow and to measure the benefits to patients of the adaptive treatment paradigm utilizing patient reported outcomes in a first-of-kind study.

1. To individualize the planning margins used for treatment, we will assess the impact of the different uncertainties on patient-specific planning margins. We determine the dosimetric uncertainties for patients during planning and delivery through the daily adaptive process. In so doing, we will determine the relationship between the dose distributions and the associated treatment outcomes.
2. To perform retrospective clinical studies using patient data, we determine the relationship between dosimetry from plans developed using the optimized patient-specific margins (plans from (1) that are robust to uncertainties) and retrospective, clinical outcomes. This data will be used to inform daily adaptation and plan quality criteria for a prospective clinical protocol.
3. To develop (with our clinical collaborators) a first-of-kind study to measure the efficacy of daily adaptive treatment with individualized planning margins, using clinical and quality of life (patient reported) outcomes, and to compare these against the conventional treatment approach, where a single treatment plan with population-based treatment margins is utilized for all treatment fractions.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer patients
* Locally advanced

Exclusion Criteria:

-
Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC

Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.

Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Eligibility Criteria:
Inclusion Criteria:

* ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
* Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
* No prior systemic treatment for non-squamous NSCLC
* Negative in EGFR\&ALK\&ROS1
* Main organs function is normal

Exclusion Criteria:

* Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
* Symptoms of brain metastases cannot be controlled and treated within less than 21 days
* Have participated in other clinical trials of anti-tumor medicine within 4 weeks
* Get any severe diseases or the ones that cannot be controlled
Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects.

All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.

Right bundle branch block is an exceedingly frequent complication in heart surgery, and especially in patients who have undergone surgical closure of a ventricular septal defect which is the most common congenital heart disease. How this bundle branch block effects the right ventricle of the heart on a long-term basis for this group of patients, is still unknown.

As a part of a PhD-study we therefore will try to illustrate this by echocardiography, MRI, exercise testing and other investigations 15 to 20 years after the surgical procedure. The study population thus consists of three different groups: 1. Patients whom undergone surgical closure of ventricular septal defect without postoperative right bundle branch block, 2. VSD-operated patients with right bundle branch block and 3. Healthy controls with no significant medical issues matched on age and sex. By carrying out the tests mentioned the right ventricles systolic function, diastolic function, the patients maximal exercise capacity and a lot of other parameters will be evaluated in the three groups of patients and compared amongst each other. The perspective therefore is the ability to point out a specific group of patients with an inferior outcome and with a possible need for further intervention. An additional perspective is to increase the awareness of protecting the bundle branch during the operation.

Eligibility Criteria:
Inclusion Criteria:

* Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby

Exclusion Criteria:

* No chart to be found
* No EKG to be found
* Known bundle branch block prior to the surgery
* Other arrythmias
* Use of ventriculotomy
* Other disease than VSD
* Pacemaker or other metallic implants
* Pregnancy
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis

Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of patientMpower platform from patient \& healthcare professional perspective, impact of active engagement and self-monitoring using patientMpower platform on Patient Reported Outcome Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and correlation between patient-reported PROMs \& FVC and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
* daily unrestricted access to smartphone or tablet device at home.
* demonstrated understanding of protocol and correct use of Spirobank Smart spirometer and patientMpower platform.
* able and willing to perform spirometry every day at home.
* willing to give written informed consent

Exclusion Criteria:

* significant confusion or any concomitant medical condition which would limit the ability of the patient to record symptoms or use a home spirometer on a regular basis.
* new prescription of antifibrotic therapy for IPF (e.g. pirfenidone, nintedanib) within 4 weeks before baseline visit.
* recent exacerbation of IPF or other clinically significant change in the patient's medical condition in 4 weeks before baseline visit
Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab

The purpose of this study is to explore the safety and efficacy data in clinic patients who have been treated with Natalizumab for more than 60 continuous infusions.

This is a retrospective chart review and data analysis of patients at the MS Center of Northeastern New York , P.C., who have had greater than 60 continuous infusions prior to the IRB approval date. Only records that are in existence at the time of the IRB review and approval will be accessed for inclusion in the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis patients treated with long term use of natalizumab--60 or more infusions (5 years)

Exclusion Criteria:

* Patients who do not have 60 or more infusions (5 years) of Natalizumab.
Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.

Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In the USA, a total of 492.000 tibial fractures were reported per year by the National Center of Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a prevalence up to 30%.

From a clinical point of view, there is limited knowledge on how to avoid RM during IMN. Clinical estimation of tibial alignment is difficult, resulting frequently in RM following IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed after surgery when the opportunity for direct revision has passed. Both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of RM when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of tibial shaft fractures.

Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View (CARV)' was determined in order to improve the accuracy of alignment control during IMN of tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM following IMN of tibia fractures. However, a prospective trial is needed to determine the performance of CARV in clinical practice. Therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the CARV-protocol. The following primary research question was defined: can the risk for RM following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients (≥18 years) with an open or closed tibia shaft fracture, who are eligible for IMN, will be asked to enroll in the study

Exclusion Criteria:

* The following exclusion criteria will be used: age \<18 years, fractures not suitable for IMN and pathological fractures.
Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis

Patients with idiopathic scoliosis (IS), especially children and adolescents, require regular follow-up evaluations. Ultrasound imaging offers a reliable, radiation-free method for assessing spinal curvatures in the coronal and sagittal planes. While manual labeling in traditional ultrasound is error-prone, automated labeling reduces inaccuracies but still needs further validation, particularly in the sagittal plane. This study compared three-dimensional (3D) ultrasound assessments with conventional X-ray images--the clinical gold standard. And it is aimed to evaluate the validity and reliability of ultrasound measurements-Ultrasound Curve Angle (UCA) and Ultrasound Lamellar Angle (USLA)-against established radiographic benchmarks like Cobb's angle, Thoracic Kyphosis (TK), and Lumbar Lordosis (LL).

This study was structured into two fundamental segments: 1) a dual-operator analysis focused on evaluating both intra- and inter-operator reliability of the UCA and USLA; and 2) a validation study of radiographic indices, specifically the coronal Cobb angle, TK, and LL, in correlation with UCA and USLA measurements. Initially, 100 patients diagnosed with IS were subjected to both standard radiographic and 3D ultrasound examinations. Owing to various exclusion criteria, 20 patients were subsequently disqualified from the study, resulting in a final sample of 80 patients for statistical evaluation. Reliability assessments were conducted using the Intraclass Correlation Coefficient (ICC). Furthermore, the validity of the UCA and USLA measurements was rigorously analyzed by comparing them against established radiographic benchmarks, utilizing Pearson correlation coefficients and Bland-Altman plots for comprehensive evaluation. All expected or unexpected adverse events from this study will be recorded and monitored.For comprehensive analysis, participants were systematically categorized based on multiple demographic and clinical parameters: coronal angle (either ≥20° or \<20°), gender (male or female), age (either\>14 years or ≤14 years), and nutritional status (classified as normal or abnormal).

Eligibility Criteria:
Inclusion Criteria:

* Patients with IS who were cooperative with ultrasound procedures.

Exclusion Criteria:

* Patients with spinal disorders such as Marfan's syndrome, a history of ankylosing spondylitis, or spinal neurofibroma.
* Patients with severe medical or psychiatric conditions that could potentially impact the study results.
Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring. Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing elective cesarean section; secondary, to compare the duration and quality of analgesia and anesthesia

On arrival in the recovery room the ICG non-invasive blood pressure cuff will be placed on the left arm, two sensors will be placed above the clavicle on each side of the neck, and two sensors will bw placed on either side of the thorax at midaxillary line corresponding to the level of the xiphoid process. Using a computer- generated sequence of numbers, patients will be randomly allocated in one of the two groups: 6 mg (1.6 mL) levobupivacaine + 20 µg fentanyl (GL6 group) or 8 mg (2 mL) levobupivacaine + 20 µg fentanyl (GL8 group). Continuous spinal epidural anesthesia (CSE) will be performed with patient in sitting position: a 18-gauge Tuohy needle will be inserted into the L2-L3 interspace using the loss of resistance of saline technique to identify the epidural space; a 27-gauge Withacre spinal needle will be then placed through the Tuohy needle until the dura mater wwill be punctured and isobaric undiluted levobupivacaine plus 20 µg fentanyl was administered. Afterwards, an epidural catheter (Espocan, B.Braun, Melsungen, Germany) wwill be inserted 4 cm into the epidural space.

Eligibility Criteria:
Inclusion Criteria:

* pregnant undergoing elective Caesarean delivery at term of singleton pregnancy, with American Society of Anesthesiologists physical status of class I or II, without preeclampsia or diabetes,

Exclusion Criteria:

* Patient with a known allergy to amide local anesthetics and other drugs, with BMI≥40 kg/m2, cardiologic or systemic disease, in treatment with antihypertensive or anticoagulant