cyrilzakka/clinical-trials huggingface dataset:
Development of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy

This observational study aims to develop and validate the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy." The study involves conducting in-depth interviews with surgeons who perform shoulder arthroscopy to identify key factors influencing their surgical satisfaction, including individual, patient-related, and surgical equipment-related factors. Based on the insights gained from these interviews, a comprehensive questionnaire will be developed. The questionnaire will then undergo validation processes, including assessments of content, construct, criterion, and reliability, to ensure it accurately and consistently measures surgeon satisfaction. The final validated tool is intended to provide a reliable method for surgeons to self-assess their satisfaction with shoulder arthroscopy procedures, contributing to improved surgical practices and outcomes.

The "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy" is being developed to address the need for a standardized tool to evaluate surgeon satisfaction in the context of shoulder arthroscopy. This study is structured into two primary phases: survey development and validation.

Phase 1: Survey Development In the initial phase, semi-structured interviews will be conducted with a diverse group of surgeons who specialize in shoulder arthroscopy. These interviews will explore various dimensions of surgical satisfaction, including technical factors, patient outcomes, surgical equipment performance, and team dynamics. The qualitative data obtained from these interviews will be analyzed to identify recurring themes and factors that are crucial to surgeon satisfaction. Based on these findings, a draft questionnaire will be developed, ensuring that it comprehensively covers all relevant aspects of the surgical experience.

Phase 2: Validation Process Once the questionnaire is drafted, it will undergo a rigorous validation process. Content validity will be established by consulting with a panel of experts in orthopedic surgery and psychometrics to ensure that the questionnaire items are both relevant and exhaustive. Construct validity will be tested using factor analysis to determine the underlying structure of the questionnaire and to ensure it accurately measures the intended constructs of satisfaction. Criterion validity will be assessed by comparing the questionnaire outcomes with established benchmarks or other validated tools. Additionally, the questionnaire's reliability will be evaluated through test-retest and internal consistency measures Cronbach's alpha.

Eligibility Criteria:
Inclusion Criteria:

* Orthopedic Surgeons:Must be a licensed orthopedic surgeon actively performing shoulder arthroscopy procedures.
* Participants must be willing to provide informed consent and participate in both the questionnaire development (including interviews) and the validation phases of the study.
* Participants must be proficient in the language in which the questionnaire is administered to ensure accurate and meaningful responses.

Exclusion Criteria:

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A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.

The investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention, which is a psychotherapeutic technique, for improving insomnia symptoms in adults. Previous research has tested this technique for insomnia and found overall positive results. However, during the last decades very few studies have examined paradoxical intention. Therefore the investigators wish to conduct a pilot study examining the effects in a modern context.

In the 1970s, Ascher and Efran developed paradoxical intention (PI), instructing sleep onset insomnia patients to stay awake instead of trying to sleep. The American Academy of Sleep Medicine confirmed PI's effectiveness. However, between 2006-2018, PI use in clinical practice declined.

The study will investigate PI's acceptability, mechanisms, and predictors for effectiveness. It involves a pilot trial with 40 insomnia patients in Sweden, recruited through advertisements and screened through web questionnaires, phone interviews, and sleep diaries. Criteria are based on insomnia research standards and Diagnostic and Statistical Manual Fifth Edition (DSM-5), including insomnia with common comorbidities.

Participants will undergo baseline assessments, then receive four weekly online PI modules, including educational texts, behavioral experiments, and homework. Weekly therapist meetings via phone or video will support and troubleshoot issues.

Post-treatment, 10-15 participants will be randomly selected for qualitative interviews to evaluate their experiences with PI, focusing on sleep patterns, text volume, therapist support, and homework's impact on sleep quality and treatment adherence. Interviews will be audio-recorded and analyzed thematically.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing three screening phases: a web-based questionnaire, a telephone interview with a structured assessment, and a 7-day sleep diary completion.
* Screening resulting in diagnosis of insomnia, including co-morbid insomnia.
* Participant should fulfill the following DSM-5 criteria. (1)Difficulty in sleep Initiation, maintenance, or early morning awakening. (2)Frequency and duration of at least three nights per week and has been present for at least three months.(3) Problems persist despite candidates having had adequate opportunity and circumstances for sleep. (4) The sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
* Age above 18 and Swedish resident and language proficient.

Exclusion Criteria:

* Severe depressive episode with suicidal intentions or actions
* Current or past diagnosis of psychotic or bipolar disorders
* Current substance use disorder
* Recent changes in psychopharmacotherapy (within the last three months) or use of "as-needed" hypnotic medications during the trial.
Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases.

The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.

Eligibility Criteria:
Inclusion Criteria:

* Subject with a history of at least one heart failure (HF) hospitalization (as defined in the European Society of Cardiology or American College of Cardiology/American Heart Association guidelines), emergency department (ED) visit, or urgent office visit necessitating intravenous (IV) diuretic or augmentation of oral diuretic, IV inotropic, or IV vasodilator or other HF parenteral therapy within 15 days prior to device implant
* Subject has an implanted Reveal® XT device (less than 15 days post implant);
* Ejection Fraction (EF) less than 40 percent
* Patient with access to a telephone line
* Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties
* Age greater than 18 years old
* Patient is willing and able to comply with the Clinical Investigation plan and willing to remain available for follow-up visit, through study closure
* Patient (or patient's legally authorized representative) is willing and able to sign and date the study Informed Consent

Exclusion Criteria:

* New York Heart Association (NYHA) Class IV (chronic or ambulatory)
* Planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
* Patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
* Severe chronic obstructive pulmonary disorder (COPD)
* Chronic Atrial Fibrillation at time of enrollment
* ST segment elevation at time of electrocardiogram
* Cognitive disease
* Pregnancy or childbearing potential and not on reliable contraceptive
* Anticipated compliance problem or participation in another competitive trial
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.

OBJECTIVES:

Primary

•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.

Secondary

* Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients
* Assess significant toxicities in this group of patients and compare to a non-elderly population.
* To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy.
* Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy.
* Assess progression-free survival and overall survival for this group.
* To determine the feasibility of accrual.

STATISTICAL DESIGN:

Using a one sample binomial design, with 37 patients there was 83% power to detect a null hypothesis of a 45% therapy completion rate versus an alternative hypothesis of a 66% rate assuming a one-sided 5% alpha. The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy
* Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus
* Life expectancy greater than 6 months
* Baseline laboratory values as described in protocol

Exclusion Criteria:

* Active infection requiring antibiotics at the time of starting chemotherapy
* Prior pelvic radiotherapy \> 25% of bone marrow
* Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs
* Past history of bone marrow transplantation or stem cell support
* Known history of central nervous system (CNS) metastasis
* History of prior malignancy that required prior systemic therapy
* Clinically significant cardiac disease
* Uncontrolled diabetes mellitus
* Any signs of intestinal obstruction
* Participation in an investigational drug study within three weeks prior to study entry
* History of psychiatric disability or other central nervous system disorder
Air Leakage Under Continuous Positive Airway Pressure

The software embedded in recent continuous positive pressure devices enables the analysis of the level of leakage that occurs during treatment around the mask or from the mouth. However, there is no clear threshold defining when it would be appropriate to implement means for correcting these leaks. In addition, the calculation methods used to detect/measure leaks and the terminology used vary according to the manufacturers of continuous pressure devices, which also complicates the clinical interpretation of the leakage reports provided by the various devices.

In daily practice, when a patient complains of unintentional leakage, technicians adjust the mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those strategies are not always effective in reducing leakage or patient's complaints. A better understanding of the mechanisms beyond leak appearance for a given patient could lead to individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory effort, sleep position or sleep stages may contribute to leak emergence.

A recent exploratory study has proposed a genuine analysis method of determining factors of unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional leakage during auto-CPAP treatment and providing an etiological analysis of unintentional-leaks via a software named APIOS.

Due to the innovative nature of the analysis, it appears necessary to validate it onto a population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no descriptive data of the distribution of the determinants of unintentional leaks in such a population. From this perspective, the investigators aim to retrospectively analyse some polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with auto-CPAP.

The primary objective of this study is to identify and describe the determinants of unintentional leaks for a population of patients with OSA and treated with an auto-CPAP device

The secondary objectives are:

1. to evaluate the concordance of the determinants of leaks according to different leak thresholds (0 l/min ; 5l/min ; 10l/min : 20l/min).
2. to describe any technical problems that arise in relation to the analysis of leaks in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Sleep recordings from patients with OSA treated via auto-CPAP and monitored with Brizzy® device (including measures of non-intentional leaks) between June 1st and December 31th, 2017.

Exclusion Criteria:

* The patient opposes the usage of his/her data
* Minors or adults under any kind of guardianship
* Fixed pressure
* Bilevel positive airway pressure devices
* Adaptive servo-ventilation
Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays

To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.

Two hundred and sixty children with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital will be included. The lifestyle questionnaire will evaluate the lifestyle changes of children with developmental delays during home isolation and release from home isolation during the COVID-19 pandemic in Taiwan. The parents of children with developmental delays will fill out the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with developmental delays

Exclusion Criteria:

* children without developmental delays
Smart Parents--Safe and Healthy Kids

The purpose of the proposed study is to assess the effectiveness of the addition of a single-session child sexual abuse (CSA) prevention module (Smart Parents - Safe and Healthy Kids) on improving parents' knowledge, attitudes, and behaviors regarding CSA prevention for parents already receiving parent-education services. The investigators hypothesize that parents who receive the parenting curriculum and the CSA prevention module will (a) demonstrate significant improvement in CSA-related awareness (i.e., knowledge, attitudes) and protective behaviors from pre-test to post-test, and (b) demonstrate higher scores on CSA-related awareness and protective behaviors as compared to parents who only receive the parenting curriculum.


Eligibility Criteria:
Inclusion Criteria:

1. Parent or caregiver \> 18 years old
2. Parent or caregiver of at least one child under 13
3. Enrolled in PAT

Exclusion Criteria:

1. Parent/caregiver does not speak English
2. Parent is mandated (i.e., court-ordered) to attend parent-training program
Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection.


Eligibility Criteria:
Inclusion Criteria

* Written informed consent will be obtained prior to enrollment into the study. If any patient is unable to give consent, it may be obtained from next of-kin or a legal representative if in accordance with local laws and regulations
* Hospitalized, ≥18 years of age
* Male or non-pregnant, non-lactating female who is post-menopausal, surgically sterilized or is using birth control pills, contraceptive implant or injection (ex: NORPLANT®; DEPO-PROVERA®), intra-uterine device, barrier methods with spermicide, or abstinence. (Effective contraception should have been in place for at least two months prior to study entry and must continue for at least 30 days after treatment discontinuation)

Exclusion Criteria

* Patients with underlying immunodeficiency disease or patients requiring chronic treatment with known immunosuppressant medications including \>5mg/day prednisone
* Active or treated leukemia, or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the past year or which is anticipated to begin prior to the Test-of-Cure visit; or any known or suspected malignancy to the abdomen
* Concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal catheters or shunts, plasmapheresis or hemoperfusion
Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases

Morning urine samples of patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and minimal degenerative nephropathy confirmed by renal needle biopsy in our hospital from November 2020 to January 2022 were collected. By scanning the morning urine samples of corresponding patients with microhyperspectral imager, machine learning and deep learning were used to classify microhyperspectral images, and the classification accuracy was greater than 85%. Thus, hyperspectral imaging technology could be used as a non-invasive diagnostic means to assist the diagnosis of glomerular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, minimal change nephropathy confirmed by renal biopsy;
* Had not received hormone and/or immunosuppressive therapy before renal biopsy;
* Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

Exclusion Criteria:

* There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc.;
* Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
* Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
* Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
* Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor.
Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients

The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia patients.

Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 9 A.M. in the morning of the first drug administration day, after blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomic and genetic analyses.

Subjects should take the investigational product by themselves every morning for 8 weeks. On the days of 2nd, 4th, 6 and 8th week, blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomics will be conducted by visiting the clinical trials center. On the days of 2nd, 4th and 6th week, the study drug will be taken after blood and urine collection.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 35 to 55 years at the time of screening
* Serum LDL cholesterol (LDL-C) level ≤130 mg/dL
* Must be reliable and willing to make themselves available during the study period
* Must be willing to give blood sample for genotyping

Exclusion Criteria:

* A subject with present clinical manifestation or past medical history of hepatic, renal, respiratory, neurologic, hematologic, oncologic, psychiatric, cardiovascular or endocrine disease, except hyperlipidemia and mild hypertension (SBP \< 160 mmg, DBP \<100 mmHg).
* Administration of lipid lowering agent within 2 weeks before the first study drug administration.
* A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which could influence the absorption of the study drug.
* A subject with a history of drug abuse, or a positive urine drug screening test
* A subject who takes or should take any medication that can influence lipid lowering effects or metabolic profiles of the study drug during the study period. (Investigators judge the wash-out period of the previously used medication before the administration of the study drug.)
* A subject who has participated in any other clinical trial within 3 months before the study drug administration.
* A subject who is judged to be ineligible to participate in the study due to abnormal clinical laboratory results or other reasons by investigators.
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer

Several large adjuvant trastuzumab trials have demonstrated improved overall survival, in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).

At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment.

At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as "standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed early stage HER2-positive breast cancer
* Planned trastuzumab therapy for early stage breast cancer
* ≥18 years of age
* Able to provide verbal consent
* Normal LVEF (\>53%) before trastuzumab therapy

Exclusion Criteria:

• Contraindication to transthoracic echocardiography or MUGA