cyrilzakka/clinical-trials huggingface dataset:
Ultrahypofractionation and Normal Tissue Toxicity

This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.

The names of the two study groups in this research study are:

* Proton Radiation Therapy (PBT)
* Conventional or "Photon" Radiation Therapy (XRT)

This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.

Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.

Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.

The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
* Prior chemotherapy is permitted
* Ability to understand and the willingness to sign a written informed consent document
* No contraindication to MRI
* Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible.

Exclusion Criteria:

* Person who is pregnant or breastfeeding.
* Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
* Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
* Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
Urdu Version of Oxford Shoulder Score Scale: Reliability and Validity Study

The primary goal of this study is to translate and culturally adapt the Oxford Shoulder Score Scale into Urdu, as well as to assess its reliability and validity in the Urdu-speaking Pakistani community. This research will also look at the relationship between Oxford Shoulder Score Scale and the Shoulder Pain And Disability Index and Short Form - 36 scores for shoulder pain.

The English version of the Oxford Shoulder Score Scale will be translated and culturally modified into Urdu. The Oxford Shoulder Score Scale, as well as other correlation measures, will be disseminated among 104 individuals in the Pakistani Urdu speaking community, who will be chosen using a convenience sample approach and based on pre-defined inclusion and exclusion criteria. For the intra- and inter-observer validity and reliability of the Oxford Shoulder Score Scale, Shoulder Pain And Disability Index, and Short Form - 36, questionnaires will be filled on the same day by two observers, with a two-hour gap between the first and second application. This is the inter-observer evaluation. The third application for the intra-observer evaluation will be completed after 7 days. Statistical Package of Social Sciences Version 26 will be used to enter and analyses the data. The internal consistency will be assessed using the Cronbach alpha value. The test-retest reliability will be assessed using an inter-class correlation coefficient. The content validity, criteria and construct validity, as well as responsiveness, of the Oxford Shoulder Score Scale scale will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Documented cognitive impairment
* Patient with shoulder instability
* Acute traumatic shoulder injury

Exclusion Criteria:

* Age under 18 years
* Recent surgery
* Pain origination from neoplasms
* Systemic arthritic
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients, 18 to 65 years of age, inclusive
* Diabetes mellitus Type 2, diagnosed at least 3 months before screening
* Treated with stable dose of metformin for at least 4 weeks prior to screening
* Treated with stable dose of Angiotensin-converting enzyme inhibitor (ACEI) for at least 4 weeks prior to screening
* Body mass index (BMI) 18 to 38 kg/m2, inclusive

Exclusion Criteria:

* Positive for HIV-1, HIV-2, hepatitis B or hepatitis C infection
* Pregnant or lactating females
* Type 1 diabetes or secondary from of diabetes
* History or evidence of proliferative diabetic retinopathy or clinically significant neuropathy
* Clinically significant hepatic disease
* Clinically significant renal impairment
* History or evidence of clinically significant cardio-vascular disease or disorder
* Acute infection or current malignancy requiring treatment except for excised basal cell carcinoma
Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System

The goal of this clinical trial is to investigate the possible role of levonorgestrel intrauterine system use(LIU) in the pathogenesis of temporomandibular joint disorder (TMD). In this clinical trial, levonorgestrel intrauterine system patients (n=30) aged 25-50 and control group patients (n=30) with the same demographics and age range are used. The main questions it aims to answer are:

To compare the frequency of temporomandibular dysfunction in women using the levonorgestrel intrauterine system with the control group of the same demographic and age range.

The levonorgestrel intrauterine system use group consisted of 50 women who had previously a mirena implanted by a gynecologist at least 3 months ago due to menstrual bleeding and pelvic pain.

The control group included 50 randomised healthy women who had regular menstrual cycles and were not taking any medication.


Eligibility Criteria:
Inclusion Criteria:

* Being a woman
* Having used an intrauterine device for at least 3 months
* Being between the ages of 18-50
* Being in American Society of Anesthesiologists-1 and American Society of Anesthesiologists-2 systemic status

Exclusion Criteria:

* Patients with craniofacial syndrome
* Patients with a history of head and neck trauma
* Isolated muscle tenderness or previous surgery on TMJ
* Patients with rheumatological disorders
* Patients with an additional gynecological disease other than endometriosis
* Lack of cooperation with the patient.
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

Patients will receive Iressa daily until either disease progression or intolerable toxicity develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once weekly for the first 8 weeks, a physical exam and complete blood count with differential will be performed.

For the first year, a physical exam, bloodwork will be performed monthly. Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year. After the first year a physical exam, bloodwork will be performed every 3 months and bone marrow biopsies every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically documented acute myelogenous leukemia and either not be a candidate for myelosuppressive chemotherapy due to age or comorbid disease; or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 30 days.
* ECOG performance status 0, 1 or 2
* Age \> 18 years
* Adequate kidney and hepatic function
* Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea.
* Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or donor lymphocyte infusion.

Exclusion Criteria:

* Uncontrolled active infection
* Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy
* Current chemotherapy or chemotherapy within the last 4 weeks.
* Pregnancy or nursing mothers
* Infection with HIV
Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)

The investigators hypothesize that the association of I-ONE® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (PEMFs) (I-ONE® therapy) of the foot or ankle.

Study design; spontaneous, prospective, randomized study with control group.

Purpose of the study:

evaluate the functional clinical improvement of the foot/ankle joint with algodystrophic pathology following a standard rehabilitation treatment and home biophysical treatment and local biophysical stimulation with I-ONE® therapy (IGEA SpA).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type I CRPS according to the Budapest criteria (table 1)
* Type I CRPS involving the ankle or foot
* Onset of CRPS type I up to a maximum of 3 years after the symptomatic event
* Pain on visual analog scale (VAS) scale quantified as intensity at least ≥ 5 at recruitment
* Pharmacological treatment with first infusion cycle of neridronate

Exclusion Criteria:

* Neurological pathologies (stroke, degenerative, traumatic pathologies)
* Local neurological impairment (type II CRPS), confirmed by a conduction test or similar
* Cardiac pacemaker, treatment site malignancy
RISC Panel Remnant Sample Collection

The primary objective of this study is to evaluate the usability and clinical utility of the Synovasure® RISC™ Panel.

The secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain and/or inflammation to be used for future research.

The Synovasure® RISC Panel™ constitutes a single source of pre-operative biomarker testing with high predictive value for the diagnosis of single or multiple arthritis conditions, that may correspond to a relative level of inflammation and post-operative complication and infection risk in patients with knee pain and/or inflammation.

The aim of this clinical performance post-market clinical follow-up (PMCF) study is to evaluate the usability and clinical utility of the Synovasure® RISC Panel™ using comparative analyses between the suspected diagnosis, patient demographics, conditions, symptoms, medical history and the Synovasure® RISC Panel™ results. The secondary objective of this study is to create a repository of well-characterized synovial fluid samples from patients with knee pain and/or inflammation to be used for future research.

Investigators will perform arthrocentesis as part of the patient's standard of care. Remnant samples will be transferred in the tubes included with the Synovasure® Arthritis Specimen Transportation kit, in accordance with instructions and the requisition form. Additional case report forms (CRFs) to collect demographic, and clinical data beyond what is included in the requisition form and the Panel results accession identification (ID) will be provided. Sample collection and shipment to CD Laboratories (CDL) may be limited to Monday-Wednesday. A maximum of three samples per transportation kit will be shipped as soon as the samples are collected. CDL will perform RISC™ Panel testing and identifiable results will be provided to enable the centers to pair the test results with clinical outcome data. De-identified leftover remnant samples will be frozen and all data, including any available clinical outcome data, will also be entered into a de-identified database of results and made accessible to all participating investigators for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with knee pain and/or inflammation and planned arthrocentesis

Exclusion Criteria:

* Patient is unwilling or unable to give oral consent
* Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
* Patient had an arthrocentesis of the index joint less than 2 weeks from the planned arthrocentesis
* Insufficient synovial fluid sample of \< 1.5 mL
* Patient age \< 18 or \> 89
FCI in Post-operative Low Grade Gliomas

The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.

The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan.

Standard clinical magnetic resonance imaging (MRI) is the mainstay of diagnosis in brain lesions. It is a powerful imaging technique for the non-invasive investigation of the brain and has been an incredibly successful technology since its commercialisation in the 1980s largely due to its excellent spatial resolution and ability to distinguish multiple tissues in multiple planes. When exogenous contrast agents are used, MRI can demonstrate the breakdown of the blood-brain barrier and provide additional physiological information.

However, standard MRI has limitations in determining the subtypes of tumours, which originate from different cells and therefore contain differing types of proteins. The aim of this project is to establish if there is a difference in the relaxometry (i.e., loss of MRI signal over time) characteristics of different brain lesions using Field Cycling Imaging (FCI), which is a new technology being developed at the University of Aberdeen.

FCI combines the use of a moderately high magnetic field with the ability to probe low magnetic fields so that one can preserve image resolution while also exploiting the high contrast present at low magnetic fields. This provides quantitative data on the molecular dynamics in the tissues, completely non-invasively.

For this study, the research team will use FCI to try to establish if there is a difference in the relaxometry characteristics of different low-grade gliomas. Ten patients with postoperative low grade glioma will be included. Each participant will be asked to undergo one FCI scan only. FCI images will be acquired on dedicated equipment, specifically built for the purpose of imaging human volunteers and patients. Participants will carry on receiving their routine clinical care before and after their scan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with post operative low-grade glioma.
* Capacity to give informed consent.
* Capacity to co-operate with the scanning procedures and duration.
* Age 16 and above.
* Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner.
* Participants who meet the safety criteria for undergoing an MRI scan.
* Participants must be mobile enough to be positioned onto the FCI scanner couch.

Exclusion Criteria:

* MRI-incompatible conditions, as detected in the MRI safety screening form.
* Restrictions to mobility that would prevent the correct positioning in the scanner by trained research radiographer (e.g., severe kyphosis).
* Participants who are unable to give fully informed consent.
* Women who are pregnant.
* Participants who are unable to understand or communicate in English.
* Patients who suffer from claustrophobia.
The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.

The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.

Eligibility Criteria:
Inclusion Criteria:

* physical status ASA (American Society of Anesthesiologists) I
* scheduled for elective strabismus surgery under general anesthesia
* aged between 3-16 years

Exclusion Criteria:

* have a neurological or cardiovascular disease
* receiving antiepileptic or another medications known to affect EEG or ECG
Immune Monitoring of Prevalent Kidney Transplant Recipients Using Torque Teno Virus: a Single-Center, Prospective Cohort Study

Kidney transplant recipients (KTRs) suffer from immunosuppression-related adverse events (iRAEs), such as infections and malignancy from chronic immunosuppression exposure but are also at risk of graft loss from rejection with under-immunosuppression. Biomarkers that predict both iRAEs and rejection and allow individualisation of immunosuppression exposure are lacking. While plasma viral DNA levels of Torque Teno Virus (TTV), a widely prevalent, non-pathogenic virus, have been shown to predict both iRAE and rejection in incident KTRs within 1 year after transplant, its role for prevalent KTRs on stable immunosuppression is unclear.

The investigators hypothesise that plasma TTV levels can predict iRAEs and rejection in KTRs on stable immunosuppression and propose a pilot study to pursue three specific aims: (1) To determine the TTV levels and its relationship with clinical factors affecting the 'net state of immunosuppression' in prevalent KTRs. (2) To analyse the prognostic value of TTV levels for iRAEs and rejection in prevalent KTRs. (3) To compare the prognostic performance of TTV levels to commonly available biomarkers and composite prognostic scores.

The investigators seek pursue these aims by performing a single-centre, prospective, observational cohort study of 172 KTRs on stable immunosuppression for more than 3 months. TTV levels will be measured, using the TTV R-GENE® kit, upon recruitment and when kidney allograft biopsies are performed. Subjects will be monitored for iRAEs and rejection for at least 12 months.

The study will provide data on the distribution of TTV levels in a prevalent cohort of KTRs and analyse its relationship with clinical factors and important clinical outcomes. If the study indicates that TTV may be predictive of iRAEs and rejection, the investigators aim to conduct further studies including interventional studies using TTV levels to guide immunosuppression. Ultimately, the investigators aim to use TTV as a biomarker to optimise long-term immunosuppression exposure, reduce the risk of iRAEs without increase in rejection, and improve long-term outcomes for KTRs.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients on follow up at Singapore General Hospital (SGH)
* More than 21 years old
* On stable doses of immunosuppression for more than 3 months

Exclusion Criteria:

* Titration of immunosuppression (e.g. for rejection or infection) less than 3 months ago
* Active infection requiring treatment
* Less than 21 years old
* Unable to provide informed consent
Study to Predict Risk of Relapse in Bone Marrow Cell Samples From Younger Patients With Acute Myeloid Leukemia

RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a patient's risk of relapse and plan better treatment for acute myeloid leukemia.

PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well it works in predicting risk of relapse in bone marrow cell samples from younger patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* To validate the accuracy of the My Profile Pediatric Assay to predict risk of relapse in pediatric patients with non-M3 acute myeloid leukemia (AML) who responded to cytarabine-based induction chemotherapy.

Secondary

* To validate the continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy, while controlling for the simultaneous effects of the following clinical and laboratory variables: age, WBC, ethnicity, cytogenetics, Flt3-ITD, NPM1, MRD, and bone marrow (BM) donor availability.
* To validate the accuracy of the prespecified low versus high relapse indicator variable (I_L/H) as a predictor of relapse after induction therapy.
* To validate the accuracy of the prespecified I_L/H as a predictor of relapse after induction therapy, while controlling for the simultaneous effects of the following clinical and laboratory variables: MRD, age, WBC, ethnicity, cytogenetics, Flt3-ITD, NPM1, and BM donor availability.

OUTLINE: Archived bone marrow mononuclear cells are analyzed by single cell network profile assay, the My Profile™ AML Risk of Relapse Assay. Molecular markers analyzed include Flt3-ITD, NPM1, and MRA. Results are then correlated with each patient's clinical data including patient's age, race/ethnic background, gender, treatment received, and outcomes.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients with confirmed non-M3 acute myeloid leukemia

  * Treated on COG-AAML03P1 or COG- AAML0531 protocols

    * Samples from COG-AAML0531 can come from either treatment arm, but these samples need to be independent from any patients who donated samples assayed in study COG-AAML11B2
  * Patients with Down syndrome are excluded
* Cryopreserved bone marrow mononuclear cell (BMMC) samples collected at diagnosis, prior to start induction therapy

  * Samples must have been cryopreserved at central lab within 3 days of draw at clinical site
  * Target of 10 X 10\^6 cells frozen
* Patients' clinical annotations required after unblinding

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics