cyrilzakka/clinical-trials huggingface dataset:
Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients

The purpose of this study is to retrospectively collect and analyse the characteristics of breast cancer patients with bone metastasis, and compare the impact of intensive follow-up with standard post-operative surveillance on survival of Chinese breast cancer patients.

Breast cancer is one of the most common malignant tumors in women, and the incidence rate is gradually increasing, accounts for the first place in the incidence of female malignant tumors. Bone metastasis is the most common distant metastatic site for breast cancer, accounting for approximately 70% of all patients with advanced breast cancer. About 26%-50% of breast cancer patients with primary metastases are bone. Autopsy results showed that the overall incidence of breast cancer bone metastasis was about 47%-85%.

Postoperative routine screening for bone metastases in breast cancer patients, whether domestic or foreign, is not recommended in most guidelines. These recommendations were based on two prospective randomized controlled trials in Italy in 1990s, indicated that a bone scan every six months or annually didn't provide a survival benefit to the patient. However, there were researches showing that about 11% of patients with asymptomatic breast cancer have bone metastases, suggesting that early screening might detect more patients with asymptomatic bone metastases. The meta-analysis also pointed out that early screening may prolong the disease-free survival of patients. Besides, the imaging techniques have advance rapidly and remarkably since then. New trials are needed to figure out whether imaging screening of asymptomatic patients should be routinely performed to detect more asymptomatic bone metastases needs further investigation.

Eligibility Criteria:
Inclusion Criteria:

A. Histologically proven breast cancer confirmed by biopsy or pathological examination of the resected tumor.

B. Histologically confirmed breast cancer patients, fulfilling any of the following:

1. . Multiple bone metastases indicated by bone scan
2. . Bone scan positive, and proven by other imaging examinations, including computed tomography (CT), magnetic resonance imaging (MRI) and X-ray.
3. . Bone scan positive, with clinical symptoms, including bone pain, pathologic fracture, spinal cord compression and so on.
4. . Bone metastases indicated by PET-CT
5. . Histologically proven bone metastases

Exclusion Criteria:

A. No bone metastases confirmed by pathological examination B. Bone metastases secondary to other malignant tumor other than breast cancer C. Secondary primary tumor
A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants

The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2
* Body weight ≥40.0 kg

Exclusion Criteria:

* History of clinically significant infection within 4 weeks of dosing on Day 1
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
* History of clinically significant allergic reaction to any drug, biologic, food or vaccine

Other protocol-defined inclusion/exclusion criteria apply
A Midazolam Drug Interaction Study With PF-04171327

The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and/or females (non-childbearing potential) volunteers.
* Cortisol level within normal reference range of the laboratory.

Exclusion Criteria:

* History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.
* History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.
* Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.
Reliability of Multiple-Repetition-Maximum Tests in Patients with Cardiovascular Disease or Risk Factors

Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important. The gold standard to prescribe resistance training intensity or monitor longitudinal changes is the 1-Repetition-Maximum (1-RM) test. However, particularly for unexperienced individuals, this test may not be recommendable due to the high load and an increased risk of injuries. Alternatively, there are several published formulas to estimate the 1-RM based on a multiple-repetition-maximum (or repetition-to-failure) test. However, these formulas have been primarily tested in healthy individuals. Moreover, the reliability of the 1-RM estimation based on two tests with different submaximal weight is unknown. Therefore, the present study evaluates the agreement of the 1-RM estimation (based on different formulas) between two Multiple-RM tests with different weight in 50 patients with cardiovascular disease (heart failure, coronary heart disease, atrial fibrillation) or cardiovascular risk factors (type 2 diabetes, arterial hypertension).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* At least one of the following cardiovascular diseases / risk factors:
* Heart failure
* Coronary heart disease
* Atrial fibrillation
* Arterial hypertension
* Type 2 diabetes mellitus
* Clinically stable for ≥ 4 weeks
* Medical clearance to perform resistance training / strength testing
* Signed written informed consent

Exclusion Criteria:

* Pregnancy
* Acute infection
* Chronic joint inflammation
* Knee, hip, ankle, wrist, elbow or shoulder pain
* Known osteoporosis (T-value ≤ -2.5)
* Uncontrolled hypertension (≥160 mmHG systolic / ≥100 mmHG diastolic)
* Known cerebral or thoracic aneurysm
The Influence of Internet + Combined Family Empowerment Management Mode on Treatment Compliance of PATIENTS With CKD

To explore the effect of Internet + combined family empowerment management mode on treatment compliance of patients with chronic kidney disease (CKD) and the correlation between psychological status and disease progression.

To explore the effect of Internet + combined family empowerment management mode on treatment compliance of patients with chronic kidney disease (CKD) and the correlation between psychological status and disease progression. A total of 100 patients with CKD treated in our hospital from October 2020 to October 2021 were screened and analyzed, and randomly divided into combined group and traditional group according to the number table method, with 50 patients in each group. The traditional group was implemented with the conventional chronic disease management mode, and the combined group was implemented with the Internet + combined family empowerment management mode. The differences in compliance, self-efficacy, psychological status and renal function indexes of each group were compared. Mmas-8 compliance score and GSES score showed an increasing trend. Compared with the traditional group, T2-T4MMAS-8 score and GSES score in the combined group were significantly increased with statistical differences (P \< 0.05). The levels of BUN, Scr, SAS and SDS showed a decreasing trend. Compared with the traditional group, the levels of four indexes T2-T4 in the combined group were significantly decreased with statistical differences (P \< 0.05). BUN, Scr were positively correlated with SAS and SDS (P\< 0.05). Internet + combined family empowerment management model can effectively improve renal function, negative psychological clarity, self-efficacy and medication compliance of CKD patients, which is worthy of clinical promotion.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled subjects meet the diagnostic criteria for CKD and are confirmed to be CKD based on laboratory findings.
* After assessment, it was determined that the subject's communication was barrier-free
* No abnormal feedback was found after evaluation.
* The patient received dialysis treatment for more than 3 months, and the clinical data were complete. This is the first time they've been to the hospital.

Exclusion criteria:

* The female patient is pregnant and lactating.
* Kidney transplant patient.
* People with language communication disorders or mental diseases.
* Participants received other psychological guidance and health education interventions during the study period.
Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation

The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of rocuronium-induced moderate neuromuscular blockade in patients during renal transplantation

34 patients undergoing renal transplantation or elective surgery are divided into 2 groups, including transplantation group (S group,n=17) and control group (C group, n=17). Patients age 18 to 65 and ASA glass I-III

Anaesthesia is induced and maintained with i.v. propofol and an opioid. Neuromuscular monitoring was performed at the adductor pollicis muscle with acceleromyography (TOF-Watch®SX, Organon Ireland Ltd, a division of Merck and Co., Dublin, Ireland). After calibration of the TOF-Watch®SX, an i.v. bolus dose of rocuronium 0.6 mg/kg is given for tracheal intubation, with maintenance doses 0.15mg/kg if T2 reappears to maintain moderate NMB Patients receive sugammadex 2 mg/kg i.v. for reversal when surgery finish and T2 reappears.

Venous blood samples of C group(within 12hours) and S group(within 48hours) are obtained before administration of Sug and at specified time points after administration of Sug to determine plasma concentration using HPLC-MS. Time from start of administration of Sug to recovery of TOF ratio to 0.7, 0.8, 0.9 and other clinical indicators are also recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergo emergency renal transplantation under general anesthesia(CLCR≤30ml/min),or patients undergo elective surgery in supine position(CLCR≥80ml/min)
2. Patients age 18 to 65
3. ASA glass I-III

Exclusion Criteria:

1. patients suffering obstructive sleep apnea hypopnea syndrome or BMI≥28kg/m2
2. Pregnant or lactating women
3. neuromuscular disorders, hepatic dysfunction, cardiac disease, a history of malignant hyperthermia, or
4. allergic history during general anesthesia
5. patients receiving aminoglycoside antibiotics, anticonvulsants, magnesium,fusidic acid,toremifene and/or flucloxacillin
Comparison Study of Insulin Glargine and NPH Insulin

This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.

In this study the investigators will be comparing two long-acting insulins, insulin glargine and NPH insulin. The trial will be evaluating differences in effectiveness, safety and cost between the two agents when used in patients on more than 80 units or 1unit/kg long-acting insulin. The investigators hypothesis is that patients switched from lantus to NPH will have improved blood glucose control.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients at 22 Providence Medical Group primary care clinics
* Diagnosis of type 2 diabetes mellitus
* Currently using greater than 80 units/day of insulin glargine or greater than 1 unit/kg/day of insulin glargine
* Current A1C \> 8.5% (within 3 months of randomization)

Exclusion Criteria:

* Diagnosis of type 1 diabetes mellitus
* Age \> 85 years
* Self-reported history of severe hypoglycemia or hypoglycemia unawareness
* Hospice/limited life expectancy
* Current enrollment in Providence Medical Group Medication Assistance Program
* Current use of a GLP1 agonist (i.e., liraglutide, exenatide, exenatide extended-release)
* End stage renal disease (i.e., dialysis or estimated glomerular filtration rate \<15 ml/min/1.73m2)
* Cirrhosis
* Unstable coronary artery disease or chronic heart failure (i.e. an exacerbation or hospitalization within 6 months pre-randomization)
* Psychiatric condition that prevents adequate follow-up (i.e., \> 3 missed follow-up visits within a 3 month period or persistent non-adherence to dosing or monitoring recommendations)
* Active alcohol or drug abuse
* Inability to provide informed consent
Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery

The aim of the study is to evaluate whether loco-regional analgesia reduces post operative pain compared to intravenous analgesia, in patients undergoing cardiac surgery in minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment group) or intravenous analgesia (control group), at the end of the cardiac intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing minithoracotomy for cardiac surgery, \> 18 years old

Exclusion Criteria:

* psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent
Carbon Dioxide (CO2) and Cognitive Impairment

The purpose of the study is to better understand the biological mechanisms of carbon dioxide (CO2)-induced cognitive impairments.

Participants will complete 2 study visits. Each study visit will consist of a 2.5-hour exposure session. Concentrations of CO2 during the exposure session will be either 600 ppm (control) or 2500 ppm (exposure). The order of the exposure sessions will be randomized and the exposure sessions will be at least one week apart. Up to two participants will take part in each exposure session.

During each exposure a neurobehavioral assessment (Strategic Management Simulations or SMS) will be administered. Venous blood (30 mL) will be collected from subjects immediately before entering the chamber and immediately after the exposure. A subset of subjects (n=12) will also undergo a 60-minute fMRI scan. Another subset of subjects (up to 10) will not complete the SMS during the exposures but will undergo computer-assisted intravital microscopy (CAIM) to exam the conjunctival microvasculature before and after the exposure.

Eligibility Criteria:
Inclusion Criteria:

* History of COVID-19 vaccination
* Weigh at least 110 pounds

Exclusion Criteria:

* Colorblindness
* Inability to hear verbal instructions
* Cardiovascular disease, including a history of stroke
* Diabetes requiring the use of insulin
* Pregnancy
* Current asthma (an asthma attack within the past five years)
* Medications for or history of anxiety disorder diagnosis or panic attacks
* Medications which may affect cognition such as beta-blockers and CNS depressants

Temporary Exclusion Criteria

* Respiratory symptoms in the previous four weeks
* Use of sedating cold/allergy medications in the previous week
* Use of marijuana in the previous week
* Consumption of alcohol in the previous 24 hours

Additional Exclusion Criteria for Subjects undergoing the fMRI scan:

* History of head trauma or neurosurgery or neurological disorder
* Ferrous metal implanted in or on the body, electrical devices such as a pacemaker, nonremovable ferrous jewelry
* Surgical pins or plates above the neck
* History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask
* Lead or iron tatoos
* Claustrophobia
* Back problems that would prevent the subject from laying still comfortably for up to 90 minutes

Additional Exclusion Criteria for Subjects undergoing CAIM

* Current or recent contact lens use
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.


Eligibility Criteria:
Inclusion criteria:

* Patients receiving a primary kidney from a donor aged \> 65 years
* In the Eurotransplant Senior Program
* Recipients of de novo cadaveric kidney transplants

Exclusion criteria:

* Multi-organ recipients (e.g., kidney and pancreas)
* Patients receiving a kidney from a non-heart beating donor
* Patients who are recipients of A-B-O incompatible transplants
* Patients with already existing antibodies against the HLA-type of the receiving transplant
* Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
* Patients with thrombocytopenia, with an absolute neutrophil count of \< 1,500/mm³ or leucopenia or hemoglobin \< 6 g/dL
* Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive
* Evidence of severe liver disease
* Females at randomization who will be not considered post-menopausal

Other protocol-defined inclusion/exclusion criteria may apply
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.

This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care

C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.

The research study procedures include screening for eligibility and the collection of data and biospecimens. Non-operative management is offered as part of routine clinical care.

It is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study .

Participants enrolled on the study will remain on study for up to 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants with T3, T4, or node-positive non-metastatic rectal cancer.
* Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
* Participants must be 18 years of age or older.
* ECOG 0-2.
* Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX
* Participants must be eligible for long course chemoradiation to 40-54 Gy.
* Participants must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Participants must not have any other organ cancer evident at the time of enrollment.
* Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
* Participants must not be actively or planning to be pregnant or breastfeeding
Retaining Cognition While Avoiding Late-Life Depression

This study will adapt Problem Solving Therapy (PST) for individuals with mild cognitive impairment (MCI) as an intervention for preventing major depression (DEP). PST will be modified so as to be provided to both MCI probands as well as their support person. The primary aim is to examine the effectiveness of PST in individuals with MCI and the support person, at preventing DEP over 12 mos. in MCI probands. We also will examine the effect of exercise on preventing depression.

The Recall Study (Retaining Cognition while Avoiding Late-Life Depression) is a study for adults 60 and older who have noticed mild memory changes in themselves or a loved one. Mild memory changes may feel stressful and therefore increase an individual's risk of developing depression. This research project will test whether Problem Solving Therapy (PST) is successful in preventing major depression for those living with mild cognitive impairments. We will also examine the effect of modest exercise on mood. You will participate in 8 to 12 PST sessions over 16 weeks. All treatments are provided at no cost and there is compensation for participation.

Eligibility Criteria:
MCI participant Inclusion Criteria:

1. =\> age 60
2. Modified Mini Mental State (3MS) =\> 80
3. MCI diagnosis
4. Adequate physical and sensory function to undergo NP assessment
5. PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.

MCI participant Exclusion Criteria:

1. Major Depressive Episode or anxiety disorder within the past 1 year
2. Currently taking an anti-depressant
3. History of Bipolar Disorder or Schizophrenia
4. Drug or alcohol use disorder within 12 months
5. Currently taking anti-anxiety med \>4x/week for the past 4 weeks

Support person Inclusion Criteria:

1. =\> age 18
2. Modified Mini Mental State (3MS) =\> 80
3. Normal Cognitive Function
4. Adequate physical and sensory function to undergo NP assessment
5. PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.

Support person Exclusion Criteria:

1. Major Depressive Episode or anxiety disorder within the past 1 year
2. Currently taking an anti-depressant
3. History of Bipolar Disorder or Schizophrenia
4. Drug or alcohol use disorder within 12 months
5. Currently taking anti-anxiety med \>4x/week for the past 4 weeks