cyrilzakka/clinical-trials huggingface dataset:
Early Detection of CMP in Patients With Breast Cancer Using Cardiac Magnetic Resonance

Breast cancer is the most common cancers among women worldwide.Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. The investigators will focus on the cardiotoxicity of pyrotinib and apatinib which belong to the new tyrosine kinase inhibitors in respective chemotherapy among more subjects.

Breast cancer is the most common cancers among women worldwide. Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. We have focused on the field of chemotherapy-related cardiomyopathy. Using the unified magnetic resonance sequences and parameters, effect of chemotherapeutic drugs on the myocardium are studies. Our team's previous pilot study has found that chemotherapy-related cardiomyopathy (CMP) may be predicted within one week after chemotherapy initiation. The specific intervention timing, and the sensitivity and specificity of the early screening indicators are to be explored. At the same time, in patients with human epidermalgrowth factor receptor-2-positive breast cancer, our team observed the change of blood pressure, exercise tolerance and myocardial structure, function and tissue characteristics in patients who used tyrosine kinase inhibitors (pyrotinib and apatinib). This is a supplement to the existing drug knowledge. We are planning to further explore whether it is related to the patient's pre-existing cardiovascular diseases, drug type, dose or dosing. There are no published data addressing the above two research areas. The overall goal is to explore the commonness and specificity of myocardial changes after chemotherapy in breast cancer patients and to predict the development of CMP through multimodality imaging and clinical indices. We aim to propose the CMP time window in respective chemotherapy among more subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years old.
* Invasive breast cancer confirmed by Pathology
* Left ventricular ejection fraction ≥ 50%
* Having not received any prior systemic anti-cancer therapy for advanced disease
* an Eastern Cooperative Oncology Group（ECOG） performance status 0-1
* Providing written informed consent

Inclusion Criteria for Control group:

* Absence of known systemic diseases
* Normal examinations
* Age between 18-70 years old.
* Providing written informed consent

Exclusion Criteria:

* Age \<18 years old or \>70 years old
* Documented coronary artery disease or prior angiography for coronary artery disease (\>50% stenosis).
* Patients with bilateral invasive breast cancers.
* Patients with metastasis of breast cancer confirmed by imaging or pathology
* Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate \< 30 ml/min/1.73 m2.
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) an Observational Prospective Cohort Study

This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the vaccination campaign in the current monkeypox outbreak.

Of the 23,837 cases of monkeypox reported in the European Region of the WHO, 7.037 have been identified in Spain, according to the National Epidemiological Surveillance Network (RENAVE). Most of diagnosed individuals are men born in Spain, being nearly 40% HIV positive. The clinical evolution was satisfactory, although 3-7% of cases required hospitalization.

Given the limited number of available doses of the MVA-BN vaccine, it has been recently approved its use as a single intradermal dose. However, this posology can be more reactogenic than subcutaneous injection and there is limited data on its immunogenicity and effectiveness in people living with HIV (PLWH), which account for about half of the monkeypox cases in the current outbreak.

The present observational study has been designed to investigate the humoral and cellular immune responses following monkeypox vaccination in PLWH.

Eligibility Criteria:
Inclusion Criteria:

1. Adult individuals of ≥18 years old.
2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
3. Has understood the information provided and capable of giving informed consent.

Exclusion Criteria:

1. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
Lifestyle Intervention Trial in Obese Elderly

Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function. However, appropriate management of obesity in older adults is controversial. Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively. Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population. The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.


Eligibility Criteria:
Inclusion Criteria:

* 65-85 years old
* Obese men and women (BMI \> or equal to 30 kg/m2)
* Stable weight (±2 kg) during the last 6 mos.
* Must be sedentary (regular exercise \<1 h/wk or \<2 x/wk for the last 6 mos.)
* Be judged, during the initial screening, to be well motivated and reliable

Exclusion Criteria:

* Any major chronic diseases
* Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
* Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
* Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
* Visual or hearing impairments that interfere with following directions
* Diagnosis of dementia
* History of malignancy during the past 5 yr
* Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
* Individuals on insulin or with a fasting blood glucose of \> 140mg/dl, and/or a 2 hour post-glucose of \>250 mg/dl
* BMD t-scores of \<-2.3 of the lumbar spine and proximal femur
* serum creatinine \>2.0 mg/dl
* No commitments, life situations or conditions that would interfere with their participation in the study
A Single-center Study to Investigate How Quickly and to What Extent a Radioactive Dose of RO5285119 is Absorbed, Metabolized and Eliminated From the Body of Healthy Male Volunteers

This study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled \[14C\]-labeled RO5285119 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants, 35 to 64 years of age, inclusive
* For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last dose of study drug
* Participants who do not intend to donate sperm until at least 3 months after the last dose of the study drug

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
* Any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
* Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to a subject
* History or presence of any clinically relevant ECG abnormalities, cardiovascular or cerebrovascular disease
* History of myopathy or muscle disorder
* History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
* Any CYP3A inhibitor within 2 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
* Any CYP3A inducer within 4 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
* Infrequent bowel movements (less than once per 24 hours on average)
* Regular work with ionizing radiation or radioactive material
Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help

This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (RCT).

Most patients with chest pain referred to hospital do not have a cardiac illness. Non-cardiac chest pain (NCCP) is often followed by persistent distress and reduced quality of life, and societal costs are nearly equal to those of cardiac patients. Research suggests that face-to-face CBT is effective, but this has not been implemented as standard treatment. We plan to test an easily implementable web-based guided self-help intervention for NCCP patients.

Patients will be recruited at the chest pain unit at Sørlandet Hospital, Kristiansand, and will be recruited after they have finished their cardiac examination.

The intervention group will receive six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-Cardiac Chest Pain

Exclusion Criteria:

* Language difficulties
* Unable to perform at least moderate physical activity due to physical constraints
* Obvious cognitive impairment (e.g mentally retarded, psychotic, dementia or intoxicated)
* no regular access to a computer/tablet computer with internet connection
Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?

Transient renal insufficiency is frequently observed in the course of cardiovascular arrest. Although elevation of creatinine is reversible in a large majority of cases, severe renal insufficiency is sometimes observed and is associated with a dark prognosis. Any intervention that may limit the worsening of renal function may have an impact on patient mortality. There is currently no validated pharmacological treatment to limit the progression of ARI or to accelerate its recovery. A major challenge then concerns the detection of the reversible character of renal damage.

Renal biomarkers have been little studied in the prediction of severe ARI and mortality after cardiac arrest. The combination of TIMP2 (tissue inhibitor of metalloproteinase) and insulin-like growth factor binding protein (IGFBP7) in urine showed good diagnostic performance in the early detection of the risk of developing acute renal failure within 12 hours. Measured in the urine, the excretion of these two markers specifically reflects renal tubular lesions. Moreover, their rate seems to be strongly correlated with the severity of the tubular lesions.

Thus, it can be reasonably assumed that their very early dosing in post-cardiac arrest could detect the presence and severity of renal tubular lesions. A threshold to be defined would discriminate patients at risk of developing an ARI within 48 hours post ACR and to distinguish between severe transient and severe persistent lesions beyond 72 hours.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Cardio-circulatory arrest within 6 hours
* Person affiliated to a social security scheme

Exclusion Criteria:

* Acute renal failure requiring urgent ERA in the opinion of the resuscitator Anuria
* Chronic renal insufficiency stage 4-5 with a glomerular filtration rate estimated at less than 30 ml / min.
* Rapidly progressive renal disease (glomerulonephritis, HUS, obstruction ...) Renal Insufficiency
* Probable glomerular involvement (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)
* Pregnant or nursing women
* Patient under tutelage or curatorship or deprived of public right.
* Transplantation
* Subject involved in another search including an exclusion period still in progress at pre-inclusion
Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with advanced leukemias or myelodysplastic syndromes defined in section 4.1; Eastern Cooperative Oncology Group performance status 0-2; adequate hepatic and renal function; ability to swallow capsules; be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery or other investigational anticancer therapy; and have recovered from prior toxicities.

Exclusion Criteria:

* Patients with known CNS involvement by leukemia; plan to undergo allogeneic bone marrow transplant within 4 weeks; currently on other investigational agents; uncontrolled intercurrent illnesses; pregnant or lactating women; known to be HIV positive
Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers Turkish Version, Validity and Reliability Study

Today, there is a relationship between the increase in the use of electronic devices such as smartphones or tablets and musculoskeletal disorders. Different usage styles of various electronic devices such as laptops, smartphones and tablets affect the risk factors that may be related to musculoskeletal disorders in office workers. In addition to the use of electronic devices, the posture of the office worker's head, waist and hands while sitting are among the risk factors. Parameters such as the features of the chair he is sitting on, the height and distance of the table affect the person's posture. Evaluation of these factors is important in preventing musculoskeletal disorders.

The Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers was developed by Kluay-On et al. in 2022 and its validity and reliability were established. The aim of our study is to culturally adapt the Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers into Turkish and to examine its validity and reliability.


Eligibility Criteria:
Inclusion Criteria:

* Being an employee of Tokat Gaziosmanpaşa University
* Being an office worker

Exclusion Criteria:

* Not being an office worker
Online Self-care Training Program (MAGO Study)

This study aims to determine the efficacy of MAGO (Online Self-care Training Program for Psychologists), a person-directed, individual, occupational intervention via videoconference in six sessions on a weekly basis. By promoting self-care behaviors, it is expected to reduce burnout levels and to increase work engagement in clinical psychologists working in Chile.

Clinical psychologists are susceptible to develop burnout as a result of facing consistently emotionally taxing job demands and a high requirement for empathy. Implementing self-care behaviors can help to prevent negative consequences of work stress and the promotion of positive outcomes such as optimal professional functioning and enhanced well-being in psychologists.

The intervention is a person-directed, individual, primary occupational intervention. It will be carried out via videoconference in six weekly sessions of 45 minutes. MAGO is a program derived from Self-care Assessment for Psychology (SCAP). From a preventive perspective on self-care, items represent strategies or behaviors that may be integrated into one's professional and personal life on a more ongoing and proactive basis to promote well-functioning.

Chile has presented a slow but progressive development of e-mental health research, and Internet-based interventions are at an early stage of development in this country. Using videoconference and web-delivered questionnaires are crucial in reaching psychologists considering problems such as long distances of transportation and a tiny budget for mental health. Nevertheless, Chile scores 52 in the Global Connectivity Index, while digital technologies are highly utilized across all social strata.

Eligibility Criteria:
Inclusion Criteria:

* Chilean psychologists
* Currently working in the public sector in Chile
* Available to attend to six online sessions
* Willing to voluntarily participate

Exclusion Criteria:

* Subjects participating in psychotherapy as clients
* High scores for depression or anxiety
Indicating Direction and Angle for Cannulating of AV-fistula in Hemodialysis Patients

Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. However, button-hole cannulation can be difficult for the dialysis nurse, and failing cannulations can damage the AV fistula and increase patient discomfort. The investigators therefore will test whether a simple marking on the skin of the direction and angle of cannulation used in each specific patient could improve the probability of a successful and painfree cannulation.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease
* hemodialysis
* arteriovenous fistula
* established buttonhole technique
* informed consent signed

Exclusion Criteria:

* child
* minor
* not speaking Norwegian
* not willing to sign informed consent
iCare4Me Transitions

The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are:

1. compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home,
2. compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and
3. explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone.

Participants who enroll will agree to enroll will:

* be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and
* be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment.

Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.


Eligibility Criteria:
Inclusion Criteria:

* Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older)
* Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2)
* Willing to use technology (e.g., computer, smartphone, iPad/tablet)
* Able to complete the protocol, e.g., adequate vision and hearing
* English speaking

Exclusion Criteria:

* Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)
* Participation in another similar support or care transition trial
* Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)
Single Shot vs Continuous Interscalene Block for Rotator Cuff Repair

1. Rotator cuff have painful post surgery recovery.
2. Single shot interscalene with oral analgesics may or may not be enough
3. Continuous nerve block may be too much for the surgery
4. The idea is to compare two techniques to see if the two techniques can improve patient pain control and satisfaction.

After consent patients will be randomized to one of the two groups: Control Group or the Experimental Group. Patients will be blinded to the group assignment.

In the Control Group the patient will be given single shot interscalene block using ultrasound technique following established guidelines. The procedure will be done after starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patient. Following accepted aseptic guidelines the nerves will be visualized at the base of the neck using ultrasound machine. Once proper nerve roots or trunks visualized 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses.

In the Experimental Group, after placement of monitors, the nerves will be visualized using ultrasound machine. There after a catheter will be placed. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for the surgery via the catheter.

The extent of block before the surgery will be evaluated at 30 minutes post injection. Surgery will be done with sedation. Conversion of anesthetic technique to general anesthesia will be considered failure of the technique to provide adequate surgical anesthesia.

At the end of the case the patient will be taken to recovery and will be evaluated for pain. If patient is having pain of 3 or more then they will be treated as follows.

In single shot group will be offered to be blocked again or treated with oral narcotics.

In the catheter group patient will be dosed with 10 ml 1% lidocaine. If it fails to provide any relief then the catheter will be pulled back and another 10 ml1% lidocaine will be given. If still not effective then it will be replaced. Refusal of patient to replace the catheter will result in patient dropping out of the study.

Working catheter will be left in place for at least 48 hrs. Patients will be allowed to take oral pain medicines as prescribed by their surgeons. The patient will be sent home with pain pump to continuously give them 0.125% bupivacaine at 5 ml per hr with an option to get extra dose of 5 ml q hr if needed. The pain control will be monitored by phone daily till catheter comes out.

Eligibility Criteria:
Inclusion Criteria:

* adult
* rotator cuff surgery
* agreeing to regional block for pain control

Exclusion Criteria:

* pregnancy
* neuropathy
* any allergies to local anesthetics
* any contraindication to nerve blocks