cyrilzakka/clinical-trials huggingface dataset:
Response Shift in Patient Expectations and Functional Outcome

The purpose of this study is to evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome. Patients undergoing elective posterior spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* All patients with a diagnosis of a degenerative condition of the lumbar spine undergoing posterior lumbar spinal surgery at Sunnybrook and Women's College Health Sciences Centre
* Patients who have had previous lumbar surgery

Exclusion Criteria:

* Traumatic or neoplastic surgical conditions of the lumbar spine
Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening

20% of deliveries take place following an artificial induction of labor. The latter sometimes requires prior cervical ripening, of which the two most widely used methods in France are oral misoprostol and the balloon catheter, left to the discretion of clinicians.

The objective of this study is to observe which cervical maturation method patients choose when an artificial induction of labor with an unfavorable cervical status must be carried out, and to observe the patient's criteria as to the choice made, as well as their experience and their satisfaction with artificial induction of labor, in order to improve our clinical practices, the experience of childbirth, and promote patient autonomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (≥18 years old)
* Patient who underwent induction of labor between February 1, 2020 and February 29, 2021
* Patient not having expressed her opposition, after information, to the reuse of her data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed her opposition to participating in the study
* Absence of prior cervical maturation (Bishop score greater than or equal to 6 on the day of initiation)
* Gestational age less than 37 weeks, multiple pregnancy, scarred uterus, non-cephalic presentation, death in utero and severe fetal malformation (requiring neonatal resuscitation or with a palliative care plan)
* Patient for whom the triggering method was chosen by the practitioner
* Patient under guardianship, curatorship or safeguard of justice
Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer

This randomized clinical trial studies accelerated recovery pathway for discharge after surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may improve outcomes after surgery following complex abdominal operations resulting in a shorter length of stay in patients with pancreatic cancer. It may also help patients to mobilize more quickly and return to the home setting, decrease hospital-acquired infectious complications, and increase potential cost savings. It is not yet known whether an accelerated recovery pathway is better than a standard recovery pathway for discharge following surgery in patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. The use of an accelerated pathway will result in a shorter postoperative hospital length of stay for patients undergoing pancreaticoduodenectomy (PD) without an increase in perioperative complications or readmission rates.

SECONDARY OBJECTIVES:

I. The investigators anticipate lower cost, lower readmission rate, similar rate of post-operative complications (delayed gastric emptying \[DGE\], anastomotic leaks, intra-abdominal abscesses, wound infection, urinary tract infection \[UTI\], respiratory compromise, renal failure, etc.) in our study group.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients follow the standard 7-day pathway at the end of surgery.

ARM II: Patients follow the Whipple accelerated 5-day pathway at the end of surgery. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

1. Pancreaticoduodenectomy
2. Firm gland texture
3. Subjects able to provide informed consent

Exclusion Criteria:

1. Preoperative factors:

   * Congestive heart failure (CHF)
   * End stage renal disease (ESRD)
   * Chronic obstructive pulmonary disease (COPD)
   * Pregnancy
   * Albumin \< 3 gm/dL
   * Poor preoperative performance status as defined by: timed get up and go (\< 15 seconds)
   * Patients cannot be homeless or have substance dependence
2. Intraoperative factors:

   * Estimated blood loss (EBL) \> 1 liter
   * Failure to extubate at the conclusion of the case
   * Operative time \> 8 hours
   * Need for vascular resection/reconstruction
Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study

It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. While diagnoses currently rely principally on clinical neuropsychology, the typical diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The goal of our project is to identify very early imaging markers for Alzheimer's disease among patients with no report of cognitive difficulties. In order to achieve this goal, we propose a longitudinal study in an elderly population cohort.

The AMImage2 project that follows AMImage1 and MRI-3C consists of an imaging study in association with longitudinal epidemiologic cohorts (AMI and 3C). The first objective is to investigate the association between the evolution of imaging markers and the evolution of cognitive performance in normal and pathological aging. This objective will be conducted among subjects having already participated in AMImage1, thereby permitting the longitudinal study of MRI data. An MRI exam will also be proposed to 100 subjects (members of the AMI and 3C cohorts) in order to provide a third wave of MRI (for a longer-term MRI follow-up) or a second one for the participants who only had one MRI exam in the AMImage project. Our second objective is cross-sectional and will study the imaging parameters of subjects presenting signs of cognitive decline over the previous 4 years (through the follow-up conducted in the AMI cohort). Finally, an additional objective will consist in a comparison between two populations very contrasted in terms of cognitive reserve: AMI (very low education level in rural area) and 3C (higher level of education in urban area).

Eligibility Criteria:
Inclusion Criteria:

* At least 65 years old
* Be retired from agricultural profession
* live in rural area in Gironde (France)

Exclusion Criteria:

* Lefthanded
* having a dementia (MMSE \< 13)
* Having a vascular cerebral accident
* Parkinson disease
* RMI exclusion criteria
* \[18F\]-FDG PET SCAN exclusion criteria
* Poor health condition does not allowing transport to neuroimaging service
The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication

Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). A potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with IC since the macrocirculation is compromised. Inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also have a strong anti-inflammatory effect, they might be effective in patients with IC by lowering the inflammatory response. In addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis.

We hypothesise that the administration of omega-3 PUFA's in patients with IC has a synergistic effect with SET and improves walking distance after SET, by improving hemorheological parameters resulting in a better microcirculation. Second, we hypothesise that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a decrease in visceral fat mass.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Newly diagnosed intermittent claudication
* Ankle Brachial Index \< 0.8 at rest or \> 0.15 decrease after exercise
* Able to perform standardised treadmill walking test for 2 min
* Written informed consent

Exclusion Criteria:

* Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
* Heart failure or unstable cardiac status (angina pectoris class III or IV or recent myocardial infarction \< 3 months)
* Any illness with rapid evolution or a life expectancy \< 3 months
* Recent cerebrovascular accident (\< 3 months)
* Current use of fish oil supplements or \> 2 times a week dietary fish
* Pregnancy
* Fish, soybean or peanut allergy
* Contra indications for the use of omega-3 fatty acids
* Use of oral anticoagulants (coumarin derivatives)
Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors

The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.

The aim is to measure variability in plasma levodopa levels during the following three treatments:

Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts. Sequences will be in randomised order. Patient self-scores regarding mobility will be recorded, every 30 min during 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Duodopa treatment ongoing
* Hoehn \& Yahr stage 3-5 at worst

Exclusion Criteria:

* Ongoing treatment with COMT inhibitors
* Dementia
* Psychosis
* Treatment with typical neuroleptics
* Contraindications for entacapone or tolcapone
Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large B cell lymphoma and CD79A/CD79B genetic abnormality.

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There are about one second of patients suffering relapse and drug resistance. ABC-DLBCL mainly relies on the chronical activity of BCR signal, which can activate the downstream NF-kB pathway through BTK and MYD88, thereby promoting the occurrence of tumors. A study by Wyndham H Wilson et al. showed that 23% of ABC-DLBCL patients were accompanied by acquired functional mutations of the BCR component CD79A/CD79B. Zanubrutinib is a new BTK inhibitor. The goal of our trial is to assess the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large B cell lymphoma and CD79A/CD79B genetic abnormality.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as diffuse large B cell lymphoma
3. CD79A/CD79B genetic abnormality
4. Subjects with untreated or relapsed/refractory DLBCL
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
10. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike
2. Diagnosed as grey-zone lymphoma
3. Diagnosed as primary mediastinal large B-cell lymphoma
4. Diagnosed as CD20 negative diffuse large B-cell lymphoma
5. Active malignant tumor need be treated at the same time
6. Other malignant tumor history
7. Serious surgery and trauma less than two weeks
8. Systemic therapy for serious acute/chronic infection
9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
10. Vaccination with live attenuated vaccine less than 4 weeks
11. HIV-positive, AIDS patients and untreated active hepatitis
12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
13. Patients with a history of mental illness
14. Researchers determine unsuited to participate in this trial
Analysis of Personality Characteristics and Psychological Capital Factors on the Leadership of Pediatric Clinical Nurses

Survey Methods In this study, a questionnaire on nursing leadership and influencing factors was distributed online through Wenjuanxing, an online questionnaire platform. The nursing department and the head nurse of the department where the questionnaire was to be distributed were first contacted and they agreed, and the researcher joined each department's nurses' WeChat group, distributed the questionnaire QR code, and explained the inclusion and exclusion criteria and the method of completing the questionnaire, emphasizing that the questionnaire was filled in anonymously. Nurses in each department were given 24 hours to participate in the response (the response time was around 30 minutes).

Quality Control The selected nursing leadership questionnaire, EPQ-RSC scale and psychological capital questionnaire all had good reliability and validity; the inclusion and exclusion criteria and the method of completing the questionnaire were explained by the researcher to the participated nurses; questionnaires that were not filled out completely or filled out with obvious regularity, and those with L scores greater than 60 on the personality trait scale were considered invalid and were excluded; the data were checked by two people after collection.

Statistical methods SPSS 22.0 was used for statistical analysis. Continuous-type data were described using the mean ± standard deviation ( ), and single-sample t-test was used for those satisfying normal distribution. Count data were described using frequency and composition ratios. Dichotomous logistic regression was used to analyze the factors influencing the leadership of pediatric clinical nurses; P\<0.05 was considered a statistically significant difference when not specifically stated.


Eligibility Criteria:
Inclusion Criteria:

* registered nurses working in clinical practice;
* those who voluntarily participated in this study.

Exclusion Criteria:

* those who did not work in the hospital during the survey period or who had not been on duty for ≥ 3 months in the past 1 year.
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).


Eligibility Criteria:
Inclusion Criteria:

1. Birth to \<18 years of age; AND
2. Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
3. Hospitalized, \<72 hours post-admission; AND
4. One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:

   1. Cough; OR
   2. Fever (oral temperature \>100.4°F/38°C); OR
   3. Chest pain; OR
   4. Shortness of breath; OR
   5. Myalgia; OR
   6. Acute unexplained loss of smell or taste; OR
   7. New/increased supplemental oxygen requirement; OR
   8. Acute respiratory failure requiring non-invasive or invasive ventilation; OR
   9. Encephalitis.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
2. Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
3. Platelet count \<50,000/µL within the past 24 hours; OR
4. Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
5. Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
6. Fibrinogen level \<75 mg/dL; OR
7. Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) \<31 mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
8. Parent or legally authorized representative unwilling to provide informed consent for patient participation.
CUHK Jockey Club HOPE 4 Care Programme - Hand of Hope

The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community.

The interactive intention-driven hand training robotic system is used for neuromuscular rehabilitation of the hand and forearm. This can help stroke survivors to regain their hand functions through motor relearning.


Eligibility Criteria:
Inclusion Criteria:

* at least six months after the onset of a unilateral ischemic brain injury or intracerebral haemorrhage
* upper-limb motor impairments due to stroke
* metacarpophalangeal and proximal interphalangeal joints of fingers can be extended to 180 degree passively
* spasticity during extension at the finger joints is lower than 3 as measured by the Modified Ashworth Scale
* detectable voluntary EMG signals from the flexor digitorum and extensor digitorum muscles of the paretic hand
* have sufficient cognition to follow the experimental instructions

Exclusion Criteria:

* have other neurological, neuromuscular, and orthopedic diseases
* have shoulder or arm contracture/pain
An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients with Early Breast Cancer Treated with Adjuvant Endocrine Therapy - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological Adverse Events)

The goal of this European observational study (Frane, Spain, italy, Spain and Greece) is to describe the quality of life related to dermatological toxicities, in adult women patients with Early Breast Cancer (EBC), treated with an ongoing adjuvant endocrine monotherapy initiated for 2 to 3 years ago before inclusion in the study.

In order to answer these objectives, the patient are completing 4 quality of life questionnaires focussed on dermatological issues (DLQI, Skindex-16, Hairdex and ItchyQoL) at the time of the inclusion.

Early Breast Cancer (EBC) diagnosis and history, demographics/clinical characteristics, skin care/sun protection care and skin toxicities since start of the adjuvant endocrine therapy will be collected by the investigator in the eCRF.

Patients will complete the questionnaires at inclusion using a webbased PRO system

Eligibility Criteria:
Inclusion Criteria:

1. Females aged ≥ 18 years at inclusion.
2. Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.
3. Still being treated with adjuvant endocrine monotherapy, initiated 2 to 3 years ago before the inclusion in the study.
4. Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.

Exclusion Criteria:

1. Patients not able to read, understand and complete Questionnaires in local language.
2. with chronic dermatological conditions (treated or not) before initiating the adjuvant endocrine therapy that could interfere with the quality of life.
3. Patients with concomitant targeted therapies with adjuvant endocrine therapy such as CDK4/6 inhibitors or trastuzumab, and patients with ongoing treatment with neratinib.
4. Patients having relevant or severe comorbidities requiring complex therapeutic treatment.
5. Patients having a persistent post-chemotherapy alopecia (at least of grade 1)
A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
3. Male or female
4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
5. ECOG performance status of 0-1

Exclusion Criteria:

1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
3. Has known history of other documented malignancy
4. Has known history of acquired immunodeficiency syndrome (AIDS)
5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
6. Has active or prior documented interstitial pneumonia/interstitial lung disease
7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
8. Has known active hepatitis B
9. Has known allergies to SHR-1921 component
10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.