cyrilzakka/clinical-trials huggingface dataset:
Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody

Hu14.18K322A is a monoclonal antibody developed at St. Jude Children's Research Hospital (SJCRH) that is made to bind to cancer cells that have a molecule called GD2 on their surface. Sometimes the human body will make an antibody to the therapeutic antibody (like hu14.18K322A) that is being given for treatment. These are called human anti-human antibodies (HAHA). When testing for HAHA in a previous cohort of patients who received hu14.18K322A, it was found that some patients tested positive for high levels of an antibody before receiving hu14.18K322A or any other anti-GD2 antibody. In this study, investigators would like to know more about the nature of this pretreatment antibody, how often is it present, and if in the laboratory it increases the killing of tumor cells.

OBJECTIVES:

* To determine whether pretreatment anti-therapeutic antibodies (PATA) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2 antibody hu14.18K322A
* To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro

In the proposed study, investigators will seek to determine the nature of this antibody that is being detected in the HAHA test for this group of patients, and if, in the laboratory, it increases the killing of tumor cells, accounting for the observation that some the patients who tested positive may have an improved outcome.

The study will analyze DNA from blood samples of SJCRH patients treated with hu14.18K322A anti-GD2 antibody. Serological studies and confirmatory genotyping studies will be performed in a laboratory at the University of Wisconsin.

Eligibility Criteria:
Inclusion Criteria:

* All participants who have or will receive treatment at SJCRH with hu14.18K322A.

Exclusion Criteria:

* Those not receiving treatment at SJCRH with hu14.18K322A.
Psychosocial Situation of Children With Rare Solid Abdominal Tumors and Their Families

Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. The aim of the present research project is to examine the psychosocial burden of the children with rare solid abdominal tumors and their family in order to draw attention to a possible psychosocial care gap in this population.

The central objective of the cross-sectional study is to show the psychosocial supply gap for families with children and adolescents affected by rare diseases in the field of oncology pediatric surgery. Among the rare diseases that are included are rare solid abdominal tumors. In order to have a comparative sample, additional data of a matched control group are collected. Central standardized psychosocial outcomes will be assessed from the perspectives of the parents and the affected child.

Eligibility Criteria:
Inclusion Criteria (families of rare disease):

* Family with at least one child between 0 and 17 years with rare solid abdominal tumors.
* Consent to participate in the study.
* Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (families of rare disease):

- Severe acute physical, mental and/or cognitive impairment of the child, so that the questionnaire survey does not appear possible and/or unreasonable at this stage.

Inclusion Criteria (control group):

* Family with at least one child between 0 and 17 years who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints
* Consent to participate in the study.
* Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (control group):

- Families of children with a congenital or chronic disease.
Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury

Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.

Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of traumatic spinal cord injury
* injury time less than six months
* sexually active

Exclusion Criteria:

* patients who had erectile dysfunction attributed to endocrine or metabolic disease order
* those who underwent surgery in the genital area, such as radical prostatectomy or penile implant
* cognitive impairment
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients

The in-MAU-tion study is conducted to determine the percentage of hypertensive participants with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined blood pressure targets. Additionally, the study assesses change in renal function (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®) therapy.

There are no interventional implications in this study. The study runs under consideration of Canadian Hypertension Education Program guidelines and as per standard practice of care. Data collection is recorded on the appropriate case report forms. The data collected consist of: patient demographics (gender, race, age, weight), blood pressure readings, heart rate, coexisting comorbidities, concomitant chronic medications (generic name and dosage), indication and dose for trandolapril (Mavik®) and patient compliance. Laboratory values (microalbuminuria, estimated glomerular filtration rate) are only collected if the data are available for each patient. For baseline values (study Day 0), any laboratory value recorded within the past year prior to the baseline visit (Visit 1) is recorded, if the value is available. As per Canadian Hypertension Education Program recommendations and as a support and educational measure, patients are provided with (1) educational tools (nutrition guidebooks) and (2) home blood pressure monitoring devices. As per research and development guidelines, blood pressure devices were retrieved at the end of the study. Approximately 8,000 hypertensive participants were enrolled in the study at up to 700 sites across Canada. Sample size estimations were based on the assumption that 67.2% of non-diabetic hypertensive participants (assumed to make up to 69% of the eligible participant population) would reach a blood pressure target of \<140/90mm Hg, while 22% of diabetes participants (31% of the eligible population) would meet a blood pressure target of \<130/80 mm Hg with trandolapril (Mavik®) therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults capable of providing consent and who have uncontrolled hypertension
* Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication.

Exclusion Criteria:

* Participants were excluded from participation in the study if they had been taking trandolapril (Mavik®), alone or in combination, for more than 1 month prior to enrollment.
Effects of Task-Oriented Station Training on Cognitive Levels and Hand Functions in Geriatric Residents of Nursing Homes

This study explores the impact of task-oriented station training on the cognitive levels and hand functions of elderly residents in nursing homes. Utilizing methods like tele-rehabilitation, face-to-face sessions, and home-based programs, this research aims to determine the most effective approach for improving the cognitive and manual skills of this population. The hypothesis driving this study is that targeted task-oriented training can significantly improve the cognitive functions and hand dexterity of elderly individuals living in nursing homes, potentially enhancing their quality of life and independence. Participants receive different types of interventions-tele-rehabilitation, direct face-to-face training, and guided home programs-to evaluate which modality most effectively supports cognitive and hand function improvements. The study's design is randomized and assesses the outcomes through various established psychological and physical tests. With an aging global population, such strategies are crucial for maintaining the independence and quality of life of our elderly, potentially reducing the need for intensive care solutions and allowing for longer periods of self-sufficiency and well-being. This summary presents the study in a straightforward manner, explaining the purpose, hypothesis, methods, and significance of the research to make it accessible to non-specialist readers.


Eligibility Criteria:
\*\*Inclusion Criteria:\*\*

* Age 65 years and older.
* Residency in a nursing home.
* Able to provide informed consent, either directly or through a legal guardian.
* Sufficient cognitive function to participate in the intervention, as indicated by a Mini-Mental State Examination (MMSE) score of 18 or higher.
* Physically able to participate in task-oriented activities, with or without assistive devices.
* Stable medical condition, with no hospitalizations due to acute illness in the last three months prior to the study commencement.

\*\*Exclusion Criteria:\*\*

* Diagnosed with severe dementia or any cognitive impairment severe enough as per the healthcare provider to interfere with participation in the study.
* Any medical condition that significantly limits physical activity or requires intensive medical care during the study period, such as unstable cardiovascular disease, severe osteoarthritis, or recent fractures.
* Participation in any other experimental rehabilitation or drug trials concurrently.
* Severe sensory deficits that would prevent participation in the tasks (e.g., severe vision or hearing loss not correctable with aids).
* Life expectancy less than 6 months as estimated by a physician.
* Significant psychiatric disorders that might impair the ability to comply with study protocols.
Evaluation of TaiHao Breast Ultrasound Diagnosis Software

The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.


Eligibility Criteria:
Inclusion Criteria:

* B-mode breast ultrasound image
* Female, age 21 or older
* Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
* Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
* At least two orthogonal views of a lesion

Exclusion Criteria:

* Breast lesion images acquired after biopsy or surgery.
* Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
* Case demonstrating administrative or technical errors
* Multiple lesions in one 2-D ultrasound image
* Breast ultrasound images with Doppler, elastography, or other overlays present
* Case with less than 2-year follow-up and without biopsy confirmation
Ketamine for Analgesia After Cesarean Section

In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

The patients were randomized in two groups:

* Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.
* Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.

The investigators recorded intra demographic, intraoperative and post operative data.

The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.

Eligibility Criteria:
Inclusion Criteria:

* full term pregnant adult patients
* Monofetal pregnancy
* scheduled for urgent or elective cesarean section under spinal anesthesia

Exclusion Criteria:

* necessity of general anesthesia during the procedure
* Post partum hemorrage
CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (\> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical, Barcelona, Spain), with FDA 510(k) Clearance and European Community Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years.

In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Chronic (\> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF.
* Life expectancy of \> 1 year with a good functional status.
* Signed informed consent.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy.
* Life expectancy of \< 1 year, or bad functional status (NYHA IV functional class).
* Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
* Previously documented sustained ventricular arrhythmias.
* Impossibility or contraindications to undergo a contrast-enhanced CMR study.
* Concomitant investigation treatments.
* Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Wireless Assessment of Respiratory and Circulatory Distress

A high percentage of patients undergoing major abdominal surgery will develop a postoperative complication. Our hypothesis is that by observing postoperative patients with continuous wireless monitoring, it is possible to detect the correlation between deviating vital parameters and subsequent postoperative complications. A prospective observational study will take place on general surgical wards with the enrolment of 500 patients in two different hospitals. Physiological parameters will be recorded for 96 hours postoperative. Data is collected preoperative, peroperative and postoperative in up to 6 months for data analyzing.

An estimated \> 230 million cases of major surgery are performed worldwide annually. Surgical interventions come with an inherent risk of complications. 15 - 30 % of all patients undergoing major abdominal surgery will develop a severe complication post-operative. These numbers correspond to the reported high postoperative in-hospital mortality, 8-9% after major upper abdominal surgery, increased in case of co-morbidities. Part of the high morbidity and mortality may be a result of delayed detection of severe complications due to the lower monitoring frequency in the general wards compared to the Post Anaesthesia Care Unit (PACU) and Intensive Care Unit (ICU). Improved observation may result in earlier detection and subsequently the possibility to implement interventions to divert a negative trajectory and ultimately reduce morbidity and mortality.

This study wish to investigate the correlation between deviating physiological parameters and postoperative complications.

In a prospective observational study, 500 patients enrolled for major abdominal cancer surgery at Rigshospitalet or Bispebjerg Hospital will be included after a signed declaration of consent.

Demographic data will be recorded together with preoperative spirometry, timed-up-and-go, Mini Mental State Examination and an electrocardiogram.

Post-operative when leaving the PACU, a wireless continuous monitoring system will be attached to the patients. The monitoring system will be recording the vital parameters 24/7.

In parallel to the wireless monitoring, the patients will receive normal treatment and monitoring (Early Warning Score) from staff on the wards. Patients are monitored for 96 hours or until they are dismissed from hospital.

Furthermore blood samples will be collected once every day for 96 hours and the patients are appointed daily by an investigator.

Exposure variables is deviation of vital parameters from normal range, socalled microevents.

Descriptive statistic will be used in analyzing the data.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 60 years old
* Elective operation performed at Bispebjerg Hospital or Rigshospitalet.
* Elective major abdominal cancer surgery.
* Operation estimated to last more than 2 hours.

Exclusion Criteria:

* Mortality.
* Non-cooperative patients.
* Patients with mini mental state examination score \< 24.
* Patients allergic to plaster or silicone.
* Patients with ICD or pacemaker
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years of age.
* Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
* Provided informed consent to participate in the study

Exclusion Criteria:

* Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
* Treated for \>7 days with mavacamten by the day of completing the baseline survey
* Enrolled in any clinical trials at the time of or within the six-month period prior to the screening
* Had heart attack requiring coronary artery bypass grafting within the three-month period prior to the screening
* Had stroke or transient ischemic attack within the six-month period prior to the screening
* Had moderate-to-severe lung disease which impacted the ability to perform daily activities of living and ability to breathe
* Had major lung (thoracic) or heart (cardiac) surgery within the six-month period prior to the screening
* Scheduled for a major surgery for the next three months, such as joint surgeries including hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eye surgeries, brain surgeries, and any other major surgeries that require general anesthesia and at least an overnight hospital stay
* Hospitalized requiring an overnight stay at the time of or within the two-week period prior to the screening
Treatment of Refractory Infantile Spasms With Fenfluramine

This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo repeat video-EEG to determine effectiveness. Patients with favorable response will have the opportunity to continue treatment for up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 12 to 36 months, inclusive
* Clinical diagnosis of infantile spasms
* Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.

Exclusion Criteria:

* Significant preexisting cardiovascular disease
* Exposure to any cannabinoid product within 14 days of screening
* Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
* Implantation of a vagal nerve simulator within 14 days of screening
* Initiation and maintenance of the ketogenic diet within 3 months of screening