cyrilzakka/clinical-trials huggingface dataset:
Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies

The purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine. Previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a way to boost their immune function and fight cancer. Information from other research studies suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in the DLI may allow for a greater effect. In this research study, we are looking for the appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given safely.

* The original marrow/stem cell donor will undergo one or two white blood cell collection procedures called leukopheresis. The cells collected from the first leukopheresis will be sent to the laboratory where the amount of white blood cells collected will be measured. If the number of cells collected at the first leukopheresis is not enough, the donor will have a second leukopheresis procedure.
* Once enough lymphocytes are collected from the donor, the CliniMACS CD25 Reagent System device will reduce the number of CD25+ Tregs. The CD25+ depleted donor lymphocytes will then be infused to the participant intravenously. Participants will be observed for about one hour after the infusion.
* One, two, four and eight weeks after the DLI, participants will return to the clinic for follow-up visits. At each visit a physical exam, questions about the participants general health, and blood tests will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies that have relapsed after HLA-A, -B, -C, and-DRBI matched allogeneic hematopoietic stem cell transplantation
* At least 2 months following hematopoietic stem cell transplantation
* Off any systemic immunosuppressive medication for treatment or prevention of GVHD, for a minimum of 2 weeks prior to study entry
* Recipient with donor chimerism of 20% or greater within 6 weeks prior to DLI
* Patient with less than 50% bone marrow involvement (% cellularity) and less than 5cm lymph nodes, in the 6 weeks prior to DLI
* 18 years of age or older
* ECOG Performance Status score 0-2
* Prior stem cell donor is medically fit to undergo leukapheresis procedure

Exclusion Criteria:

* Relapsed CML in chronic phase
* Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks prior to enrollment
* Chemotherapy within 4 weeks prior to enrollment
* Clinically significant and active autoimmune disease in donor or patient. This is defined as autoimmune disease resulting in organ dysfunction and/or requiring systemic therapy
* Evidence of active acute or chronic GVHD
* Uncontrolled infection
A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases

The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.


Eligibility Criteria:
Inclusion criteria:

- Samples having been tested positive or negative for the serological markers explored in the study

Exclusion criteria:

- to refuse to participate to the study
A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 21 years of age
* Moderate to severe active rheumatoid arthritis (DAS28 \>/= 3.2)
* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
* Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria:

* Pregnant or lactating women
* Contra-indication to RoActemra/Actemra treatment according to the local labelling
* Previous treatment with tocilizumab
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Women of childbearing potential not using effective methods of contraception as defined by protocol
Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the management of post-limb amputation pain. We will use the data that we collect to inform the design of a larger, appropriately powered study.

Lower extremity amputation is a common surgical procedure often due to limb ischemia or complications related to diabetes mellitus. Managing postoperative pain can be quite challenging in this patient population and persistent post-surgical pain is not uncommon. Peripheral nerve catheters (PNCs) that deliver a continuous infusion of local anesthetic have been shown to provide analgesic benefit dependent upon infusion duration and in the absence of catheter malfunction. Unfortunately, PNCs can be difficult to place and rates of dislodgement are estimated at 30%. Single shot regional nerve blocks using liposomal bupivacaine are much easier to perform than PNCs and can provide up to 72 hours of pain relief, eliminating the need for catheter placement. To date, no study has investigated the effects of liposomal bupivacaine compared to PNCs for post-surgical pain control. In this pilot study, we intend to compare pain scores, opioid consumption, and length of stay in patients randomized to both treatment strategies. We also intend to conduct an exploratory analysis investigating incidence of phantom limb pain one month following surgery. Our results will inform the design of a larger powered study to investigate treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status Classification I-IV
* Scheduled for primary amputation or stump revision
* English speaking

Exclusion Criteria:

* Patients unable to cooperate or consent to the study
* Allergy to local anesthetics
* Existing infection at planned needle insertion site
* BMI \> 40kg/m2
* Patients with a history of coagulopathy
* Emergency amputations
* Contralateral amputations
* Patients with a substance use disorder diagnosis
* Patients on opioids \>90 morphine milligram equivalents (MME)/day
Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain

Perioperative analgesia for surgery in carcinoma breast utilizes significant quantities of opioids as compared to cosmetic breast surgeries. Regional anesthesia reduces the need for perioperative opioids and thus may improve the outcome. The investigators decided to perform the modified pectoral nerve block ( Pec II) under vision after resection of tumor, without ultrasound and compare the postoperative analgesic and opioid sparing effects of the nerve block with ultrasound guided modified pectoral nerve block (Pec) in patients undergoing modified radical mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* 20 - 50 years
* ASA I or II undergo elective simple mastectomy

Exclusion Criteria:

* patients with diabetes mellitus i
* Intradialytic hypotension,
* chronic kidney disease and Bronchial Asthma
Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Perceptions on Self-esteem and Quality of Life

Gummy smile is a condition that promotes a disharmonious smile, altering confidence and decreasing self-esteem of many patients. Luckily, this problem in most cases is easily solved by aesthetic crown lengthening surgery. However, this is a surgery that is still considered by many patients to be painful and uncomfortable. Thereby, this study seeks both to evaluate possible changes in patients' self-esteem and self-confidence after the aesthetic crown lengthening surgery.

Periodontally healthy patients who expressed interest in undergoing ACL will be selected. Before surgery, two questionnaires will be administered: the OHIP-14/Brazil and the Rosenberg Self-Esteem Scale-UNIFESP/EPM. These tools are designed to assess patients' perceptions of self-esteem and quality of life and will be re-administered 30 days and one year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal health diagnosis (full mouth bleeding on probing - BP \<10%, clinical attachment level - CAL ≤ 3mm),
* Distance from the gingival margin to the cementum-enamel junction ≥ 3mm associated with a gingival smile and / or short clinical crowns when compared to anatomical crowns, due to the altered passive eruption or gingival overgrowth).
* Good general health

Exclusion Criteria:

* Presence of systemic changes (diabetes, heart disease, hepatitis, etc.)
* Use of medications (such as antibiotics, continuous anti-inflammatory drugs, phenytoin, cyclosporine) that may influence the response to the surgical treatment
* Diagnosis of gingivitis and/or periodontitis
* Smoking habit
* Pregnancy or lactation period
Hypertension Explored in Long-term Postpartum Follow-up in Later Life

The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life.

Women who experience high blood pressure during pregnancy are at increased risk of developing cardiac and vascular diseases later in life. They show changes in their heart, brain, and blood vessels long before they develop high blood pressure. The investigators therefore think that these changes develop slowly over the course of the life of the woman and establish their risk of later disease.

Through better understanding of the pattern of changes across multiple parts of the body over extended periods of time, the investigators aim to identify how advanced the underlying disease is for an individual and how the disease is likely to develop over the next few years. By comparing the rate of change across different parts of the body, the investigators can examine how one area affects another.

Data including images of the heart, brain and blood vessels will be acquired in women 10 to 25 years after their pregnancy. The initial analysis will focus on assessing differences between women who have had a normotensive pregnancy and those who have had a hypertensive pregnancy, both at a single timepoint and in changes within individuals over time.

This dataset will then be used in conjunction with previously acquired data in women who have experienced a hypertensive pregnancy to find out how patterns emerge across the whole body. The investigators will subsequently combine information from different measures at the same time and use the machine learning models to learn the patterns of change that occur as a person progresses from a healthy to a diseased state.

This will allow the researchers to identify patterns of hypertensive disease development and it may open doors to better interventions and therapies tailored towards individuals.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria

  * Participant is willing and able to give informed consent for participation in the study
  * Female who had a pregnancy 10 to 25 years prior
  * Able (in the investigator's opinion) and willing to comply with all study requirements.
  * Adequate understanding of verbal and written English

Exclusion Criteria:

* The participant may not enter the study if ANY of the following apply:

  * Over 10 weeks pregnant during the course of the study
  * Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status
  * Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study

For exclusion of MRI component only:

• Unsuitable for MRI based on the responses to the MRI screening form. The participant may still be included in other parts of the study.
A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy

The purpose of this study is to evaluate incidence and prevalence rates of the study endpoints (pigmentary maculopathy \[PM\]/ pigmentary retinopathy \[PR\]/Any, PM/PR/ pentosan polysulfate sodium \[PPS\], and PM/PR/Non-PPS) in relation to PPS exposure, and in participants with interstitial cystitis (IC) but not exposed to PPS; changes in visual acuity (VA) over time; participant treatment journey leading to PPS treatment, and potential risk factors associated with the occurrence of PM/PR/PPS.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have at least 6 months baseline information prior to index date (this may apply to the relevant databases, if the study participants are identified and the outcomes are ascertained via multiple linked data source) For the pentosan polysulfate sodium (PPS) Cohort
* Participants must have records in both the intelligent research in sight (IRIS) database and the closed claims portion of the Komodo claims database and have at least one record of PPS dispensing For the interstitial cystitis (IC) Cohort not exposed to PPS
* Participants must have records in both the IRIS database and the closed claims portion of the claims database; have at least one diagnosis of IC; and have no record of PPS dispensing

Exclusion Criteria:

- Evaluated based on the Komodo database. Participants will be excluded from the study if they have no information on age or sex (or both)
Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR

The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Instead of the clinical scan participants will undergo perfusion imaging by 15O-H2O PET/MR.

The clinician will receive diagnostic information based on the 15O-H2O PET scan as if the patient had not participated in the study. As such, the study has no influence on the diagnostics or treatments of the patient.

Data from the scans will be used to compare 15O-H2O PET with cardiac MR for evaluation of myocardial perfusion.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.


Eligibility Criteria:
Inclusion Criteria:

* Refered for myocardial perfusion imaging by O15-H2O PET at Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital
* \> 18 years of age

Exclusion Criteria:

* Allergic to adenosine
* Allergic to gadolinium
* Pregnancy
* Claustrophobia
* Severe Asthma
* Pacemaker or other ferro-magnetic implants
* GFR \< 30
Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion

A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively.

A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of 180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60 retrospective open PLIF patients and 60 retrospective MI-PLIF patients.

The new data will be collected prospectively by means of questionnaires. No biomaterial will be collected. The included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery.

Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months.

Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass index \>40).

Main research question: Does the CBT-PLIF provide less low back pain in the short term than the traditional open PLIF and the MI-PLIF?

Primary outcome measure

* Low back pain measured with the Visual Analogue Scale (VAS) 2 weeks after surgery Secondary Outcomes
* Low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery
* Leg pain
* Oswestry Disability Index
* Quality of life (EQ-5D-5L)
* Observed patient recovery
* Other parameters such as complications, surgical parameters (intraoperative blood loss, duration of surgery), length of stay in hospital and return to work

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years
* Degenerative or spondylolytic spondylolisthesis
* Neurogenic claudication and/or radicular leg pain
* Low grade (Meyerding grade l and ll)
* Persistent complaints for over 3 months

Exclusion Criteria:

* Previous spine fusion surgery at the same level
* Osteoporosis
* Active infection or prior infection at the surgical site
* Active cancer
* Spondylolisthesis grade lll or greater
* More than one symptomatic level that needs fusion
* Pregnancy
* Contraindication for surgery
* Severe mental or psychiatric disorder
* Substance abuse
* Inadequate knowledge of Dutch language
* Morbid obesity (body mass index \>40)
Post-stroke Fatigue, Inflammation, tDCS

Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of any race or ethnicity
* 35-80 years of age
* 6+ months post-stroke
* Have clinically present fatigue for 6 months
* Able to walk 10m unassisted

Exclusion Criteria:

* Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples)
* Inability to understand and provide written informed consent
* Multiple strokes on opposite hemispheres
* Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia)
* Severe hypertension
* Cerebellar or brainstem strokes/lesions
* Concurrent depression and/or anxiety disorders
Evidence-based Leadership in Nurse Leaders-CH

This study protocol describes a randomised feasibility trial that will evaluate the feasibility and preliminary effectiveness of the training course to improve evidence-based leadership competencies among nurse leaders working in hospitals in China.

This study will include a 6-months training intervention for nurse leaders working in hospital settings in China. About 150 nurse leaders fulfilling the eligibility criteria will be randomly allocated (1:1) to participate in the online training course about evidence-based leadership or conventional leadership training course (reading material only)

Eligibility Criteria:
Inclusion Criteria:

* Official managerial role in the study organisation (hospital, clinic, ward level), which give them an authority to act as a nurse leader and monitor, develop and evaluate the care
* Being in full time or part time position
* All sex
* Aged up to 65 years
* Working in the study sites at the time of the recruitment
* Ability to read and write simple Chinese language
* Willingness to join the study based on their own free will
* Informed consent obtained

Exclusion Criteria:

* Non-nursing professionals in leadership position (e.g. physician, psychologist, pharmacist, dietician/nutritionist, dentist, physiotherapist, radiation therapist, paramedic, occupational therapist, social worker, or disability worker)
* Speaking only other languages than simple Chinese
* Out of duty during the recruitment period for family leave, long term sick leave, study leave or any other reason
Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Different modalities for breast cancer treatments have exhausting and distressing side effects and toxicities leading to decreased compliance. Thus, repurposing drugs with accepted safety profile and possible antitumor activity becomes an eminent constraint.

Statins have been reported to have possible advantages as anticancer, and control of cancer progression. Moreover, they can sensitize cancer cells for radiotherapy. Therefore, the investigators aim to investigate the effect of (pitavastatin) added to conventional chemotherapy protocols for breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent before any study-specific procedures.
* Histologic confirmation of invasive breast cancer.
* Plans for the administration of neoadjuvant chemotherapy.
* Not currently pregnant during the study

Exclusion Criteria:

* Severe gastrointestinal disorder
* Current use of statins or fibrates for any time during the 3 months before the study
* Proven hypersensitivity to statins
* Currently on medication for hypercholesterolemia
* Strong Cytochrome P450 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with statins
* Renal impairment with a creatinine \> 1.4 mg/dl
* Hepatic impairment: Aspartate transaminase (AST)/(SGOT), Alanine Transaminase (ALT)/(SGPT) ≥ 2.5 x upper limit of the normal range (ULN), OR Total bilirubin ≥ 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR Alkaline phosphatase \> 2.5 x ULN
* Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply with the protocol procedures
* Active infections
* Cardiac failure, class I-IV
* Current anticoagulant or antiplatelet aggregation therapy
* Current lactation