cyrilzakka/clinical-trials huggingface dataset:
Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear

The aim of the study was to investigate the levels of matrixmetalloproteinases and their inhibitors in blood samples from patients with rotator cuff tears and compare with blood samples from healthy matched controls.

Background: Extracellular matrix remodeling is altered in rotator cuff tears, partly due to altered expression of matrix metalloproteinases (MMPs) and their inhibitors. It is unclear if this altered expression can be traced as changes in plasma protein levels. We measured the plasma level of MMPs and their tissue inhibitors (TIMPs) in patients with rotator cuff tears.

Material and methods: Blood samples were collected from 17 patients, median 61 (range 39-77) years, with sonographically verified rotator cuff tears (partial- or full-thickness). These were compared with 16 gender and age matched control persons with sonographically intact rotator cuffs. Plasma levels of MMPs and TIMPs were measured simultaneously using Luminex technology.

Eligibility Criteria:
Inclusion Criteria:

- degenerative rotator cuff tear verified by ultrasound

Exclusion Criteria:

* systemic joint disease such as rheumatoid arthritis
* a fracture non-union
* dupuytrens disease
* frozen shoulder
* tendinosis or rupture of any other tendons than in the rotator cuff
* disorders of the spine such as disc disease,idiopathic scoliosis, spondylitis
* cerebral or cardiovascular disease during the past year
* abdominal or bowel disease
* surgery or trauma during the past year
* any infection during the last month
* malignancy
* treatment for the last month with medications that may affect MMPs or TIMPs (tetracycline, bisphosphonates, anti-inflammatory drugs, statins)
* vigorous physical activity during the last 24 hours
* inability to understand written and spoken Swedish
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers only
* Males/females, \>/=50 and \</= 65 years of age
* Cancer patients only
* Males/females \>/= 35 years and \</= 75 years of age
* Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass

Exclusion Criteria:

* Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation
A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

The investigators have previously shown the intact protein from cod filet improves glucose regulation and serum lipid profile in overweight adults. A large amount of trimmings from various fish species such as cod is thrown away or sold at very low prices for animal feed, and analyses of the amino acid composition reveals that this can be a good protein source for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and non-water soluble proteins. In the present study the investigators will compare these fractions, by studying their effects on glucose regulation in overweight/obese adults.

Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>28
* healthy
* fasting blood glucose \<7.0 mmol/L
* stable body weight with less than 5 kg fluctuation during the last 4 months

Exclusion Criteria:

* known disease or metabolic disturbances related to overweight or obesity
* use of prescription medications that affect blood glucose, blood lipids or inflammatory status
* allergies towards fish or seafood
* undertaking a weight loss diet
* tobacco use exceeding \>15 cigarettes/day
* pregnancy or breastfeeding
* high seafood consumption
* use of dietary supplements including cod liver oil or other marine fatty acids
* allergies towards fish, milk, egg
Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients

This study is designed as a combination of phase 1 (Part A) and phase 2 (Part B). The purpose of Part A was to determine the safety, tolerability, and pharmacokinetics in patients with total thyroidectomy or near total thyroidectomy of GX-30 and it has been completed. The Part B is currently recruiting and will investigate the efficacy and safety of GX-30 compared with THYROGEN®.

Recombinant human TSH was developed to provide TSH stimulation without withdrawal of thyroid hormone. Radioiodine ablation and diagnosis with rhTSH became the standard of care treatment for patients with differentiated thyroid cancer. Stably supplying rhTSH has been the unmet need for management and follow-up procedure for thyroid remnant. GX-30 is an investigational product, developed to provide inexpensive rhTSH to patients in order to ensure stable supply of rhTSH.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily consented, after listing enough explanation for this study and investigational product.
* Minimum 19 years old.
* Minimum 50kg of body weight.
* Patients who had undergone total thyroidectomy or near total thyroidectomy due to differentiated thyroid carcinoma.
* Patient undergoing thyroid hormone administration.

Exclusion Criteria:

* Thyroid cancer excluding differentiated thyroid carcinoma.
* Thyroidectomy excluding total thyroidectomy and near total thyroidectomy.
* Patients with heart, renal, or liver failure.
* Patients with ischemic stroke or the history of ischemic stroke.
* Smoker or Ex-smoker with less than 3 months of stopping
* Patients with migraine or the history of migraine.
* Patients that the researchers do not think fit into the group, including patients failed in compliance assessment
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

nothing to add

Eligibility Criteria:
Inclusion Criteria:

* A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
* An ASA Physical Status Classification5 of 1 or 2 (see App I)
* Estimated life expectancy \> 1 year

Exclusion Criteria:

* Clinically significant systemic disease
* Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
* Predicted excised breast mass of \>750 gms
* Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
* Need for tissue flap in addition to expander
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
* Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
* Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate
Acute Kidney Injury Following Cardiac Surgery

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. The investigators sought to examine the risk factors associated with the development of AKI and renal recovery in patients undergoing cardiac surgery at San Bortolo Hospital, Italy 2014-2015.

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. The investigators sought to examine the risk factors associated with the development of AKI and renal recoveryin patients undergoing cardiac surgery at San Bortolo Hospital, Italy during November 2014 - October 2015.

Eligibility Criteria:
Inclusion Criteria:

- Adult cardiac surgery

Exclusion Criteria:

1. Missing baseline serum creatinine (defined as a serum creatinine value within 90 prior to surgery) or missing serum creatinine within 3 days before hospital discharge
2. Stage 5 chronic kidney disease (estimated glomerular filtration rate \<15 ml/min/1.73 m2 or receipt of chronic dialysis)
3. Solid organ transplant recipients
Photodynamic in Periodontal Treatment

Dental biofilm is a primary etiological factor for periodontal diseases.(1) The bacterial biofilm would induce recruitment of leucocytes, neutrophils, and T lymphocytes and the secretion of antibodies, lipopolysaccharides, and chemical inflammatory mediators such as cytokines and chemokines.(2) Thus, periodontal diseases can cause tissue destruction and results in deterioration of clinical parameters measures such as periodontal pockets depth, clinical attachment loss, bleeding on probing, bone destruction, and resulting ultimately in tooth loss.(3)

Mechanical scaling and polishing are the conventional methods in treating periodontal diseases; however, due to difficulties in access to the irregular and furcation areas, it is impossible to be used as a sole means for calculus and bacterial deposit removal.(4) For this reason, adjunctive aids like systemic and local antibiotics are necessary to be administrated However, they have many adverse effects.(5) Another adjunctive aid like antibacterial photodynamic therapy (APDT), has been introduced to periodontology to achieve bacterial eradication, with minimum side effects.(6) APDT involves using visible light with an appropriate wavelength to kill microorganisms with a photosensitizing drug.(7) APDT could be an adjunctive aid to mechanical debridement in eliminating key periodontal pathogens. This therapy was specified as an oxygen-dependent photochemical reaction upon light-mediated activation of photosensitizing materials leading to cytotoxic reactive oxygen species (ROS) generation, predominantly singlet oxygen.(8) The activity of APDT is dependent on the combination of a non-toxic photosensitizer and a specific wavelength of visible light, which is activated and can promote a phototoxic response in the presence of ambient oxygen.(9) APDT is characterized by ROS generation by PSs in response to photo illumination, which later causes cell death.(6)

Eligibility Criteria:
Inclusion Criteria:

* Each patient should have at least four teeth with a probing depth ≥of 5mm.
* Patients with good domestic oral hygiene will be include (documented with a full mouth plaque index of ≤ 30% before starting the clinical trial)

Exclusion criteria:

* Patients receiving periodontal therapy and/or antibiotics within the previous six months
* Patients with diseases or medication with an inhibitory or promoting effect on periodontal healing, including anticoagulants, anti-inflammatories.
* Pregnant or nursing women
* Patients allergic to the test product will be excluded.
Conserving Breast Surgery - Comparison of Conventional With Sonography

Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years
* Female
* Presurgical validated breast cancer

Exclusion Criteria:

* Sonographically not defined report
* Lobular breast cancer
* Extensive ductal carcinoma in situ
Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women \>=18 and \<37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).


Eligibility Criteria:
Inclusion Criteria:

* at least 2 blastocysts suitable for biopsy on day 5 of embryo development remaining after fresh transfer
* willing and able to give informed consent
* infertility as an indication for IVF/ICSI
* first or second IVF/ICSI cycle
* patients willing to accept single embryo transfer
* BMI range 18 to 35 kg/m2

Exclusion Criteria:

* any type of genetic abnormality or family history of genetic abnormality in subject or partner
* any other non-study related preimplantation genetic testing
* three or more clinical miscarriages (recurrent pregnancy loss, RPL)
* recurrent implantation failure (RIF): no positive β-hCG after transfer (fresh IVF/ICSI cycle or frozen) with no less than 6 cleavage stage embryos or no less than 4 blastocysts, all of good quality and of appropriate developmental stage
* severe endometriosis
* abnormal uterine cavity
* cycles requiring surgical sperm recovery procedures, total asthenozoospermia and/or globozoospermia
* treatment involving use of donor oocytes or use of gestational carrier
Pressure Injury、Caregiver、Knowledge Translation

Background and importance:

In 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by Taiwan joint commission on hospital accreditation. That reflects that a pressure injury is a significant heath care issue. Nowadays, it still constantly happens at hospitals, home, and nursing homes: Pressure injuries cause pain, and increase length of hospital stay, rehospitalization rate, and death rate. In current clinical practice, standardized guidelines and basic principles are followed for pressure injury management, and it is found that most of the caregivers are unsure about what are the consequences of having pressure injuries and how to manage and prevent them. Therefore, the caregivers are more passive, and feel nervous and confused. In literature, there are guidelines for pressure injury prevention and management. However, they are primarily designed for heath professionals. As a result, to achieve evidence-based practice and knowledge translation, I hope to make individual management plans for each patient, provide caring support, and follow up with patients. And caregivers can benefit from knowledge, attitude, practice, and caring effect.

Goals:

The study aims to achieve knowledge translation in nursing for pressure injury care. The caregivers of patients with pressure injuries and their family can benefit from translating of knowledge, attitude, and practice, and they can have more knowledge related to pressure injuries, and learn how to react to and care for patients. In this way, it will be possible to promote wound healing and prevent recurrence of pressure injuries.

Method:

This study is a randomized controlled trial. There are seventy participants. The experimental group receives care plans in which knowledge translation is applied, and the control group receives usual care. Generalized estimating equations, GEE, is used to assess the effectiveness of care plans with knowledge translation for patients and family with pressure injuries.

Eligibility Criteria:
Inclusion Criteria:

1. Grade 1-3 pressure injury diagnosed by medical staff.
2. The patient needs to have a caregiver.
3. The patient and the caregiver need to be older than 20 years old, (4) The informed consent of this study.

(5) The caregiver Those who understand the content of health education (MMSE\>24 points)

Exclusion Criteria:

1. The patient has \>3 disease diagnoses,
2. The patient is diagnosed by a doctor as a terminally ill patient or the life expectancy is less than 3 months,
3. There is a life-threatening acute problem (active bleeding site, acute myocardial infarction, acute bronchitis, etc. ),
4. pressure injury caused by invasive pipeline placement,
5. need to wear non-invasive positive pressure respirator, (6) need to stay in intensive care center for a long time (\>10 days),
6. need a long time For surgical patients, each operation takes \> 5 hours,
7. the caregiver has dementia,
8. the caregiver has mental illness or alcohol and drug addiction,
9. no caregiver.
Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with G-CSF may make tumor cells more sensitive to the chemotherapy drug and may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of mitoxantrone plus G-CSF in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Study the effectiveness of mitoxantrone in patients with metastatic, hormone refractory prostate cancer. II. Assess the side effects of mitoxantrone in this patient population. III. Determine whether filgrastim (granulocyte colony-stimulating factor; G-CSF) treatment can overcome chronic bone marrow suppression and facilitate a dose intensive mitoxantrone chemotherapy regimen in this patient population.

OUTLINE: This is a dose escalation study. Patients receive a 30 minute intravenous infusion of mitoxantrone once a week on day 1. On days 2-6 of each week, patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF). Treatment continues for patients who respond to therapy and exhibit no disease progression. Dose escalation proceeds until the maximum tolerated dose (MTD) of mitoxantrone with G-CSF support is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. After the MTD is determined, an additional 20-40 patients are enrolled at this dose level to examine their response to this therapy.

PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for the phase I portion of this protocol. An additional 20-40 patients may be accrued for the phase II portion of this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory adenocarcinoma of the prostate Metastatic disease required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 2 times normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Must have adequate cardiac function (LVEF at least 40%) Other: No other malignancy except skin lesions that have been completely excised No prior hypersensitivity to E. coli derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics At least 1 month since LHRH agonist and/or flutamide Radiotherapy: No concurrent radiotherapy No prior extensive radiotherapy (such as whole pelvic irradiation) Surgery: Not specified
Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker

ß blocker and digoxin effect on left atrium reservoir function are unknown. This is a randomized open label study to compare the effect of theses two molecules on left atrium function

Atrial fibrillation (AF) is responsible of significant morbidity and mortality. Management of signs and symptoms of heart failure generated by AF is at the center of the latest European recommendations . Mechanisms by which these symptoms are generated are very poorly understood. Heart rate control is one of the recommended strategies but remains poorly codified and generally follows the preferences and experiences of each local center. The European guidelines propose at least 4 molecules for heart rate control without emitting preferences for one molecule over the other due to the lack of robust randomized studies. Recently, a study comparing digoxin vs ß-blockers showed the superiority of digoxin in decreasing symptoms despite a comparable action on heart rate. On the other hand, the reservoir function of the left atrium (LA) has taken a central role in assessing signs of left heart failure and monitoring filling pressures . Other studies have demonstrated the association of left atrium reservoir strain with these symptoms .

It is commonly accepted that ß blockers decrease AF-related symptoms by a negative chronotropic effect thanks to their blocking action on the sympathetic system. While the action of digoxin on symptoms goes through a positive inotropic effect thanks to the increase in intracellular calcium .

However, the impact of these two molecules on the function of the left atrium has never been investigated. Our diagnostic hypothesis is that in addition to their action on heart rate, the improvement of symptoms noted by using b blockers and digoxin during the treatment of AF would go through an improvement LA reservoir function . The superiority of digoxin in the reduction of symptoms compared to ß blockers would be due to a greater improvement in reservoir function and this thanks to the increase in myocardial intracellular calcium.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with atrial fibrillation naïve to ß-blocker and digoxin or patients followed for Atrial fibrillation and discontinued all treatment for more than a week.
* Frequency Control Strategy Decided
* Age over 18 years
* Stable hemodynamic state
* No contraindication to digoxin or ß-blocker

Exclusion Criteria:

* Required rhythm control strategy
* Contraindication to one of the two
* Heart rate \<60 BPM
* Clearance rénale \<30 ml/mn
* Pregnant or breastfeeding woman
* Persistence of a resting heart rate \> 110
* Severe comorbidity with decreased life expectancy (advanced neoplasia, large stroke...)
Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT

This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups.

Consecutive patients with large HCC and PVTT treated with lenvatinib plus drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (Len+DEB-TACE+HAIC) or lenvatinib plus DEB-TACE (Len+DEB-TACE) from July 2019 to June 2021 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Clinical outcomes, including tumor response, TTP, OS, and TRAEs were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of HCC
* the largest intrahepatic lesion \>7 cm
* presence of major PVTT on imaging
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/B
* adequate hematologic and organ function, with leukocyte count 3.0 109/L, neutrophil count 1.5 109/L, platelet count 75 109/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase 5 upper limit of the normal, creatinine clearance rate 1.5 upper limit of the normal, and prothrombin time prolongation \<4 s

Exclusion Criteria:

* incomplete medical records
* central nervous system involvement
* previous treatment with transarterial embolization, TACE, HAIC, radiotherapy, or systemic therapy
* history of malignancies other than HCC
* history of organ transplantation
* severe cardiac, pulmonary or renal dysfunction