cyrilzakka/clinical-trials huggingface dataset:
AI Echocardiographic Screening of Cardiac Amyloidosis

Recent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and accurately assess common measurements made in clinical practice. Echocardiography is the most common form of cardiac imaging and is routinely and frequently used for diagnosis. However, there is often subjectivity and heterogeneity in interpretation. Artificial intelligence (AI)'s ability for precision measurement and detection is important in both disease screening as well as diagnosis of cardiovascular disease.

Cardiac amyloidosis (CA) is a rare, underdiagnosed disease with targeted therapies that reduce morbidity and increase life expectancy. However, CA is frequently overlooked and confused with heart failure with preserved ejection fraction. Some estimates suggest that CA can be as prevalence as 1% in a general population, with even higher prevalence in patients with left ventricular hypertrophy, heart failure, and other cardiac symptoms that might prompt echocardiography.

AI guided disease screening workflows have been proposed for rare diseases such as cardiac amyloidosis and other diseases with relatively low prevalence but significant human impact with targeted therapies when detected early. This is an area particularly suitable for AI as there are multiple mimics where diseases like hypertrophic cardiomyopathy, cardiac amyloidosis, aortic stenosis, and other phenotypes might visually be similar but can be distinguished by AI algorithms. The investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving an echocardiogram that is determined to be suspicious by EchoNet-LVH

Exclusion Criteria:

* Patients that decline consent
* Patients receiving an echocardiogram that is determined to be not suspicious by EchoNet-LVH
A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia

The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.

The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.

This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Understand the research procedure and voluntarily sign the informed consent to participate in the study
* Subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy
* Patients with platelet count ≤100×109/L or platelet count decrease ≥ 50×109/L or platelet count \> 100×109/L but need to be prophylaxis with hexapopethanolamine tablets
* Researchers believe that subjects need to be treated with hexapopal.

Exclusion Criteria:

* The subjects are conducting clinical intervention studies
* Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar
* Pregnant or lactating women
* Other conditions deemed unsuitable for inclusion in the study by the researcher.
Clinical Results of Arthroscopic Repair for Massive Rotator Cuff Tears of 14 Cases

This study retrospectively analyzed data of 14 cases of massive rotator cuff tears who were treated with arthroscopic repair by the same doctor from October 2015 to December 2017, aiming to explore the surgical methods and clinical effects of arthroscopic repair for massive rotator cuff tears.

The preoperative and intraoperative data and patient information of 14 cases of arthroscopic repair of huge rotator cuff tears performed by Deputy Chief Physician Yang Yuping of the Institute of Sports Medicine of Peking University Third Hospital from January 2016 to August 2017 sort out. Collect and organize follow-up data on the recovery and motor function of patients 6 months after surgery and the latest follow-up (February 4 to March 3, 2018). Discuss the operation method, and statistically analyze the short-term curative effect of patients undergoing the operation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as massive rotator cuff tears and treated with arthroscopic repair from October, 2015 to December, 2017

Exclusion Criteria:

* None
A Pilot Study to Test the Acceptability and Feasibility of Relaxation Rooms to Help Reduce Occupational Stress Among Healthcare Workers

Test the acceptability and feasibility of a relaxation room to reduce work stress among clinicians and collect clinician-reported outcome data after using the relaxation room.

The plan is to pilot test a relaxation room to demonstrate its acceptability and feasibility in the hospital and collect clinician-centered outcomes. This study will inform the design of a future trial using this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Clinician at Mayo working at St. Mary's hospital or the downtown Rochester campus during the study

Exclusion Criteria:

* Any physical condition that might prevent them from sitting for 20-30 minutes in the room
* Significant hearing loss that they would not be able to hear the audio stimuli
* Significant vision loss that they would not be able to see the visual stimuli
Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer

Background: This study aimed to the postoperative patients with newly diagnosed head and neck Cancer. The nurse-led counselling and after intervention improved shoulder pain, Shoulder Disability, and Quality of Life., before 2 weeks radical neck dissection and at postoperative 2, 4, 8, and 12 weeks.

Methods：Participants were identified for eligibility from the otorhinolaryngology outpatient department of a medical center in eastern Taiwan. The data of 40 patients were collected between Aug 1, 2017, and Jul 31, 2018. 40 participants were randomly assigned to an experimental (n = 20) and a control group (n = 20). The experimental group received the nurse counselling and after intervention exercise intervention , and the control group received usual care. Study tools used were the shoulder pain and disability indices, University of Washington Quality of Life Questionnaire.

Head and neck cancer (HNCs) is malignancies . Globally, HNCs was the seventh most common cancer in 2018. In taiwan, have high incidences . Primary treatments for HNCs are surgery alone or in combination with radiation . The radical neck dissection and radiotherapy inevitably damage nerves and muscles, resulting in various complications such as shoulder pain and disability; the shoulder disability and chronic neck pain occur following radical neck dissection, these complications may considerably limit the individual's capacity to undertake various tasks, affecting daily physical activities. Immediate postoperative rehabilitation has been advocated to improve these complications in HNC participants . But rticipants often fail to achieve this thresh old, which emphasizes the need to change their inactive behaviour.

Nurses are involved in patient care and have the necessary skills and knowledge about the medical and practical aspects of head and neck cancer treatment . Nurses can provide information, support and coaching to HNC participants .Nurses are in a key position to deliver an intervention to improve QoL . The investigators designed a randomised controlled trial (RCT) to investigate the effectiveness of a comprehensive 12weeks nurse-led intervention, the nurse counselling and after intervention (NUCAI), in HNC participants follow exercise intervention

Eligibility Criteria:
Inclusion Criteria:

aged \>20 years old newly diagnosed with HNC scheduled to receive surgery had no serious complications had no history of mental illness had no comorbidities had no sensory-cognitive problems could understand Chinese or Taiwanese

Exclusion criteria:

could not communicate or comprehend the questionnaires had a history of shoulder dysfunction before neck dissection had preexisting shoulder pain, dysfunction, or weakness had any disorders that could influence movement performance.
Concomitant Tracheostomy and Lung Resection

This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.

Background: Respiratory failure after lung resection is a major complication. Several studies suggest that low predictive postoperative pulmonary function is a predictive factor of mechanical ventilation (MV). In critically ill patients requiring MV, early tracheostomy may shorten the duration of MV and length of stay in intensive care.

Study objective: To determine whether concomitant tracheostomy (CT) would decrease the length of MV and improves outcome in patient with predictive postoperative forced expiratory volume in 1 second (FEV1ppo) \< 50%. We call CT a tracheostomy performed immediately after the lung resection under the same general anesthesia.

Method: An open monocentric randomized controlled trial has been design. Inclusion and exclusion criteria are mentioned below. FEV1ppo will be calculated by the mean of the scintigraphic method for pneumonectomy and by the mean of the number of resected segments for lobectomy and segmentectomy. Randomization will be made the day before the operation. The procedure will be an open surgical tracheostomy. A daily data base will be completed from randomization until discharge. The primary and secondary criteria are mentioned below.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 79 years old
* preoperative diagnosis of suspected lung cancer
* patient considered operable according to the guidelines
* 30% \< postoperative predicted FEV1 \< 50%
* informed consent obtained by patient

Exclusion Criteria:

* - age less than 18 and more than 79
* pregnant woman
* preoperative tracheostomy
* postoperative vocal cord paralysis
* postoperative diaphragmatic paralysis (except for pneumonectomy)
* neuromuscular disorders
* previous pharyngeal or laryngeal surgery
* anatomical deformity of the neck making risky a tracheostomy
* consent refusal
A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic

The purpose of this study is to determine if remote monitoring of implantable cardioverter defibrillators (ICD), compared with quarterly device interrogations in clinic, will improve patients' outcomes and satisfaction and will reduce health care costs.

Sudden cardiac death (SCD), usually due to a ventricular tachyarrhythmia, is the most common cause of death in the United States. The implantable cardioverter defibrillator (ICD) has been shown to improve the survival of patients with a history of a heart attack and a weak heart (functioning at 30% or less) and those with symptomatic congestive heart failure symptoms (hearts functioning at 35% or less). Thus, the number of patients who will require ICD therapy is expected to rise exponentially over the next several years. To facilitate the follow-up of patients with ICDs, device companies have launched systems for remote monitoring of these devices. One such system is the Medtronic Carelink Monitor. Although this system has been proven in a multicenter, prospective study to be easy to use, it is not known whether this monitor results in improved patients' outcomes and satisfaction and in reduced healthcare costs.

Comparison: Patient outcomes, costs, and satisfaction will be evaluated, comparing patients assigned to follow-up using the Medtronic Carelink Monitor versus quarterly visits to an outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must have an ICD with or without CRT for an approved indication
* Must be planning to have their devices followed-up at Duke
* Must have a telephone (land line)
* Willing and able to provide informed consent.

Exclusion Criteria:

* 18 years of age or younger
* No telephone with land line
* Unable to provide informed consent.
Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison

This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Weight of at least 50 kg

Exclusion Criteria:

* A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Positive test results for alcohol or drugs of abuse
* Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)

To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.

Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.

Eligibility Criteria:
Inclusion Criteria:

1. HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
4. Patients read, understand the consent form, and signed the study consent.

Exclusion Criteria:

1. Patient with other liver diseases;
2. Patient with concurrent hepatitis viruses or HIV infection;
3. Patients are reluctant to stop their anti-HBV treatment.
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Objectives:

* To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
* To characterize any toxicity associated with the combination oral topotecan and Temodar.
* To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.

Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar.

Eligibility Criteria:
Inclusion Criteria:

* Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection
* Age: \> or equal to 18 years
* Performance Status: Karnofsky Performance Status \> or equal to 60% at study entry.
* Renal Function: Serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/dL.
* Hematologic Status: The following baseline studies will be required before entry: total granulocyte count \> or equal to 1000/microliter; platelet count \> 100,000/microliter
* Hepatic Function: Serum SGOT \& total bilirubin \< or equal to 2.5 times ULN.
* Note: All lab parameters must have been obtained within 1 week of registration
* Consent: Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
* Corticosteroids: For patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible.
* Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are \< or equal to grade 1 \& enrollment on this protocol unless there is unequivocal evidence of progressive disease.
* Patients with Reproductive Potential: Patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy

Exclusion Criteria:

* Pregnant or breast feeding women or women or men with reproductive potential not practicing adequate contraception. This therapy may be associated with potential toxicity to the fetus or child that exceeds minimum risks necessary to meet health needs of mother
* Active infection requiring intravenous antibiotics
* Prior failure with either topotecan or temozolomide
Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.

All consecutive patients receiving transperineal prostate biopsy in the PWH will be recruited to the exposure cohort after informed consent. Antibiotic prophylaxis will not be given for patients in the exposure group. All patients will undergo transperineal prostate biopsy in the usual manner and technique, under the Ginsburg protocol. Systematic and MRI-TRUS fusion for systematic plus targeted biopsy will be performed based on the usual clinical indications, depending on the clinical need. Follow-up data will be collected, with particular interest on the assessment of infective complications.

Prospectively collected data will also be retrieved from the electronic patient record (ePR) under the Hospital Authority, to assess relevant information on infective complications for patients who received transperineal prostate biopsy in PWH and NDH from 2019 to 2023. These patients received antibiotic prophylaxis prior to their biopsies, and eligible patients will be included as the control cohort for comparison. Propensity score matching will be utilized in order to create a control group that is similar to the exposure group with balanced baseline. Statistical analysis will be performed on the retrieve data.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients in participating centres receiving transperineal USG-guided biopsy for any indication including:
* Elevated PSA
* Abnormal DRE
* Follow-up biopsy in active surveillance
* Suspicion of CAP recurrence after radiotherapy
* Follow-up biopsy after focal therapy
* Consenting to the study

Exclusion Criteria:

* Recent suspected UTI within 1 month
* Recent culture proven bacteriuria within 1 month
* History of recurrent UTI
* Indwelling urinary catheter
* Immunocompromised state
* High risk of infective endocarditis (including prosthetic heart valve, congenital heart disease, or previous history of infective endocarditis
* Incompetent or incapable of understanding the nature of the study or giving informed consent
Do Prostheses of SphinkeeperTM Migrate After Operation?

32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.

The SphinkeeperTM is a new surgical procedure in order to treat refractory fecal incontinence, which includes up to ten self-expandable prostheses. These get implanted into the intersphincteric space and due to constriction of the anal canal and better contractibility continence should be improved. Because this is a new technique, there is only limited data about its clinical efficacy.

In this study, patients, aged 18-90 years, who met the inclusion criteria and have received a SphinkeeperTM operation, were enrolled. Functional outcomes and quality of life got measured by standard questionnaires before surgery and 1, 2, 3 and 6 months after surgery. Furthermore, in routine check ups patients received endoanal anorectal manometry for pressure measurement and endoanal ultrasound to determine the position of the prostheses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
* Ability and willingness to understand and comply with study interventions and restrictions.
* Voluntarily signed informed consent after full explanation of the study to the participant

Exclusion Criteria:

* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
* Inability to communicate well with the investigator due to language problems or reduced mental development
* Inability or unwillingness to give written informed consent
Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension

A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years.
* Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
* Unmedicated IOP ≥ 22 mmHg in one or both eyes.
* Given informed consent.
* Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.

Exclusion Criteria:

* Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
* Intraocular conventional surgery or laser surgery within the past six months.
* Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
* Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
* Ocular trauma within the past 3 months.
* Progressive retinal or optic nerve disease apart from glaucoma.
* Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
* Any abnormality preventing stable applanation tonometry.
* Use of contact lens for the duration of the study.
* Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
* Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe.
* Clinically significant systemic disease which might interfere with the study.
* History of non-compliance to medical regimens or unwilling to comply with the study protocol.
* Participation in another clinical study within the last thirty (30) days.