cyrilzakka/clinical-trials huggingface dataset:
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers

This is a study evaluating the safety and efficacy of Lattice SBRT for patients with large tumors (≥ 4.5 cm) planning to undergo palliative radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed sarcoma (including extremity), thoracic cancer (including esophageal), abdominal cancer (including retroperitoneal sarcoma), or pelvic cancer.
* Planning to undergo palliative radiotherapy to a lesion ≥ 4.5 cm as measured with radiographic imaging or with calipers by clinical exam.
* ECOG performance status ≤ 2
* At least 18 years of age.
* Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study
* Ability to understand and willingness to sign an IRB approved written informed consent document

Exclusion Criteria:

* Prior high-dose radiotherapy that overlaps with any planned site of protocol radiotherapy. Patients where the Lattice SBRT fields may overlap with the low dose (\<10 Gy) region of prior radiotherapy treatments are eligible and may be treated if this is determined to be safe by the treating physician.
* Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture.
* Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the Lattice SBRT administration.

  \*Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required.
* Pregnant. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.
* Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).
Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants

The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.

Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog has primarily centered around left sided implants, a group that is characterized by a small incidence of high defibrillation thresholds (DFTs).

The mechanism of phase duration programming to improve DFTs would seem to be most effectively applied to a group of patients with a high incidence of high DFTs such as right sided implants. This study therefore aims to prospectively evaluate direct phase duration programming on DFTs in right sided implants.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets standard indication for an ICD/ CRT-D
* Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
* Pulse generator will be implanted on the right-side
* Patient is able to tolerate DFT testing.
* RV lead will be placed in the RV apex or inferior septum

Exclusion Criteria:

* Patient is pregnant.
* Patient is less than 18 years old.
* SVC coil was turned ON during DFT testing
Multi-center Study to Transplant Hepatitis-C Infected Kidneys

Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Eligibility Criteria:
Recipient Inclusion Criteria:

* Estimated glomerular filtration rate(eGFR) \< 15 ml/min/1.73 m2
* Listed for an isolated kidney transplantation
* Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent
* No available medically acceptable, compatible living kidney donor
* Subject must agree to use an effective method of birth control per protocol specifications

Recipient Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant
* Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study
* History of HIV
* HCV RNA positive
* HBV surface Ag-positive or detectable HBV DNA
* Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team
* Presence of clinically significant liver disease
* Transplant candidate requiring antibody desensitization protocol for transplantation
* Most recent calculated panel reactive antibody (cPRA) \>80%.
* Prior recipient of a non-renal solid organ transplant

Donor Organ Inclusion Criteria

* Deceased donor organ with kidney donor profile index (KDPI) ≤0.85
* HCV RNA-positive

Donor Organ Exclusion Criteria

* Known prior HCV treatment with direct acting antiviral medication
* HIV RNA-positive
* HBV Surface antigen-positive or HBV DNA-positive
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes mellitus - HbA1c below or equal to 11.0% Exclusion Criteria: - Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
Can Singing Kangaroo Improve Outcome of Preterm Infants

To assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin sessions (Kangaroo care) would improve the language development of the preterm infant. Infants will be randomized to singing or silence during the Kangaroo care from the age corresponding to 30th gestational week until term age (40 gestational weeks).

The outcomes are:

a 2- (3-)year neurodevelopmental follow up

- Bayley Scales of Infant and Toddler Development, Third Edition (in Finnish in Finland and in Swedish in Sweden)

At the age corresponding to term (40 gestational weeks)

* Auditory event related potentials (AERPs) in electroencephalography (EEG), in Helsinki cohort
* Auditory event related magnetic fields in magnetoencephalgraphy (MEG) in Karolinska cohort
* Parental stress with The State Trait Anxiety Inventory (STAI)

Eligibility Criteria:
Inclusion Criteria:

* preterm infants at 30th gestational week capable of being in Kangaroo care

Exclusion Criteria:

* intensive care preventing Kangaroo care
Loss of Cervical Lordosis in Fibromyalgia Syndrome

Purpose: The causes of chronic and widespread pain in fibromyalgia (FMS) have not been eluciated yet. Previous reports determined that posture control changed, muscle strength decreased, body posture misaligned (maladaptive posture), and functional capacity decreased in FMS patients. The aim of this study was to investigate the relationship between loss of cervical lordosis, pain, quality of life (QOL) and neck disability in patients with FMS.

Methods: A total of 107 FMS (88 females and 20 males; range of age:18-65) were included to the study. Patients were divided into two groups according to the angle of cervical lordosis measured by the Cobb method, group 1 with a Cobb angle of ≤10°, and group 2 with an angle greater than \>10°. Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.


Eligibility Criteria:
Inclusion Criteria:

Age range between 18 and 65

-Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria

Exclusion Criteria:

Patients diagnosed with known systemic (e.g., inflammatory rheumatic diseases, diabetes mellitus and systemic arterial hypertension), metabolic or endocrine diseasesas well as tumoral, neurologic or infectious diseases,

* Patients with a history of trauma and surgery affecting the neck area,
* Patients who received trigger point injection therapy for neck pain within the last 6 months,
* Patients with cervical disc herniation or myelopathy, spondylolisthesis, spondylolysis, cervicothoracic kyphoscoliosis,
* Patients who had been receiving therapy for any psychiatric diagnosis for the last 3 months and antidepressant drug use,
* Patients with history of neuropathic diseases,
* Patients with a condition affecting neck muscles, such as dystonia,
* Inflammatory muscle disease and myopathy
* Pregnant patients were not included to the study
Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs

INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA production, oxygen transport and neuronal processes. However, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular oxidative stress in the body.

Curcumin is an active component found in turmeric, known for its anti-oxidant and anti-inflammatory properties. Co-administration of iron and curcumin may influence iron, inflammatory status and/or neurotrophic markers in the body.

Intervention study with five parallel treatment groups in a randomised, double-blind, placebo-controlled design.

Study population: Healthy Participants (Male or Female) will receive daily supplements (active or equivalent placebos) for 6 weeks (42 days)

Biological samples (blood and urine samples) are collected at baseline visit (day 1), mid-point (day 21) and end-point (day 42). In addition, pertinent questionnaires (Visual Analogue Scale-Fatigue \[VAS-F\] and oral iron supplement questionnaire will be collected at the aforementioned time points.

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females (18-40 years of age)
* Healthy subjects

Exclusion Criteria:

* \<18 years or \>40 years
* Dieters
* Consumption of \>21 serving of alcohol/week
* Any allergies/health issues related to items being ingested
* Any serious illnesses or those on medication
* Any pregnant or lactating women
* Any women who are trying to conceive
* Any women taking contraceptive medication
* Any gastrointestinal disorders
* Any chronic menstrual disorders
* Any subjects who have undergone the menopause or undergoing the perimenopause transition
* Any eating disorders
* Any depression/mental disorders
* Any abnormal blood pressure levels
* Those with deficient/excess/abnormal iron levels according to United Kingdom (UK) guidelines \&/or haemochromatosis
Ultrasound Assessment of Atherosclerotic Plaque Burden and Cardiovascular Risk: A 10-Year Prospective Study

The P-SONAR study is a large, observational, prospective cohort study. The overall aim of the study is to investigate whether plaque burden estimation by 2D ultrasound of the carotid and femoral arteries may enhance cardiovascular risk prediction beyond NORRISK-2

Design: The P-SONAR Study is a prospective cohort study of all men and women aged 45-74 years attending a health check at one of 10 ultrasound clinics in Norway.

Time schedule: Study inclusion and baseline examinations took place in the period April 2022- March 20025.

Current status: Ultrasound follow-up examinations take place from January 2025 - December 2029.

Eligibility Criteria:
Inclusion Criteria: Persons attending a health check during the study period.

-

Exclusion Criteria:

* If they do not consent to participate
Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100

Patch Testing for device cream on human subjects


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18+ years
* Good health
* Signed and datad Informed Consent
* Signed and dated HIPAA

Exclusion Criteria:

* On test at any other research lab or clinic
* Known allergy or sensitivity to cosmetics or toiletries
* Pre-existing other medical conditions
* Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
* Chronic medication which could affect the outcome of the study
* Known pregnant or nursing women
* Cancer diagnosis within the past 5 years
Dose Escalation With Remicade® and Orencia®

The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e., dosing amount and frequency) and costs among a population of managed care enrollees with RA. This study will also identify changes in infliximab and abatacept dosing over time and the implication these changes may have on the costs of medication administration.

This study will be conducted in two parts. The primary analysis is a longitudinal analysis, where patients' health care claims from a period during which the patient was continuously enrolled in the health plan will be used to evaluate the primary outcome (i.e., dose escalation). The second analysis will be cross-sectional, where patients' health care claims from a fixed period of time (i.e., 2008) will be used to examine health care cost.

The final enrollment for the longitudinal portion of the study was 2,001 (1,306 infliximab and 695 abatacept patients). Final enrollment for the cross-sectional portion was 3,450 (2,646 infliximab and 806 abatacept patients). There may be some overlap in these numbers.

Eligibility Criteria:
Inclusion Criteria:

* Commercial health plan enrollees with medical and pharmacy coverage
* At least 3 claims on separate days for infliximab (HCPCS J1745) or abatacept (HCPCS C9230, J0129, J3590) administration during the subject identification period
* The 3 initial claims for abatacept occurred within a 6-week period inclusive of the index date and the three initial claims for infliximab occur within a 9-week period inclusive of the index date
* Presence of a diagnosis of RA (ICD-9-CM 714.xx)
* Continuous enrollment during the baseline and follow-up periods
* At least 18 years of age or older on the index date

Exclusion Criteria:

* Prior exposure to the index medication during the baseline period
* Diagnosis of psoriasis (ICD-9-CM 696.1), psoriatic arthritis (696.0), ankylosing spondylitis (720.0), Crohn's disease (555.x), or ulcerative colitis (556.x) in any position at any time during the study period
* Exposure to alefacept (HCPCS J0215, C9211, C9212) or efalizumab (HCPCS S0162) at any time during the study period
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity

The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.

Imaging studies using HH-SECTR will be performed to assess and quantify structural and vascular disease features associated with ROP. Weekly HH-SECTR imaging will be performed concurrently with standard-of-care weekly ROP screening. No additional treatments will be given to study patients to benefit HH-SECTR imaging (e.g., sedation, dilation, etc.). Study patients will primarily be imaged in the NICU, but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams. Because this study will evaluate diagnostic features prognostic of ROP progression and severity, HH-SECTR imaging will be performed until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first. Both eyes will undergo HH-SECTR imaging. Diagnostic imaging data will be analyzed following each imaging session. No experimental data will be used to alter the management of patients from the standard-of-care.

Research materials obtained from subjects will include digital HH-SECTR images, digital fundus photography images, and documented examination timeline as part of the standard-of-care. Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables.

The duration of the study will be 5 years. The study records and information will be indefinitely archived per NIH rules using the methods noted above.

Eligibility Criteria:
Inclusion Criteria:

* Preterm male and female infants born at 24-34 weeks gestational age and weighing \&amp;lt;1500g at birth

Exclusion Criteria:

* Infants surgically treated for ROP
* Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team
Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance

The study aims to establish a clear causal link between testosterone and threat perception and behavioral responses to threat. Namely, the study focuses whether high levels of testosterone will cause an individual to exhibit increased physiological responses to threat (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing with the threat). The threat in this study is a social threat involving public speaking, and is an outgrowth of previous research on the avoidance of health threats.

Participants in the study will receive either a single dose of 10g 1% testosterone topical gel or placebo the day prior to participating in the study. The day of the study, participants will provide saliva samples throughout the study to track testosterone and cortisol levels. Participants will be asked to complete the Trier Social Stressor Task, which includes having to give a 5 minute speech to a panel of judges. Participants will be given the opportunity to postpone giving their speech to an unspecified date. The study will focus on two types of responses to the threat of public speaking: behavioral and physiological. The behavior of interest will be participants desire to postpone dealing with the threat (it is hypothesized that those in the testosterone administration group will have an increased desire to postpone). The physiological responses include increased levels of cortisol and increased cardiovascular tone (it is hypothesized that the testosterone administration group will show an increased physiological response compared to the placebo group).

Eligibility Criteria:
Inclusion Criteria:

* Male
* In good health
* Aged 18-35

Exclusion Criteria:

* Female
* Known carcinoma of the breast or prostate
* Known sensitivity to alcohol or soy products
* Preexisting cardiac, renal, or hepatic diseases
* Obesity
* Chronic lung diseases
* Cancer
* Use of anticoagulants
* Use of insulin or a history of diabetes
* Use of corticosteroids
* High levels of physical contact with women or children
* Preexisting liver problems
Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP/ARP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP/ARP.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CP or ARP
2. ages 10-19 years
3. at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
4. access to the Internet on any web-enabled device

Exclusion criteria:

1. non-English speaking
2. inability to read at the 5th grade level due to learning problem or developmental delay
3. children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
4. patients with Shwachman-Bodian-Diamond Syndrome
5. Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
6. anticipated surgery (TPIAT or other) during study participation