cyrilzakka/clinical-trials huggingface dataset:
Radionecrosis and FDG PET

Gliomas are the most common malignant primary central nervous system (CNS) tumours. When high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional sequences is required.The Positron Emission Tomography (PET) radiotracer \[18F\]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.

Molecular imaging has been used to distinguish recurrent tumor from post-treatment changes through the use of positron emission tomography (PET) as well as other techniques. The best-studied PET radiotracer for this application is \[18F\]-fluorodeoxyglucose (FDG). Normal brain matter is very FDG-avid, making it more difficult to identify lesions and in addition, inflammation associated with radiation injury has been shown to be FDG avid.

In light of this, variations of the standard FDG protocols have been proposed in order to increase overall accuracy, including dual time point imaging (DTPI), consisting of injecting the patient with the standard radiotracer and acquiring two sets of images several hours apart, typically the normal initial images in addition to a delayed acquisition set.

There is good reason to suspect that DTPI FDG-PET would be useful a technique for characterizing lesions in the brain. It's been shown that FDG uptake by normal brain parenchyma initially increases then decreases with time, while tumor uptake typically increases and then plateaus. This pattern of increasing and then decreasing FDG activity has also been seen in inflammatory tissue. The difference in FDG uptake at different times is what allows for a better distinction between malignant and benign tissue.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Able and willing to comply with the study procedures
* The patient must be followed at The Ottawa Hospital for a tissue-proven, grade III or IV glioma.
* The patient must have been treated in the past with radiotherapy for glioma.
* A disease recurrence is suspected based on clinical symptoms and/or imaging results.

Exclusion Criteria:

* Missing information regarding tumor type and grade
* Brain biopsy in the ten days preceding DTPI FDG-PET
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent
Predictability of the Ability to Perform an Emergency Stop

Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 y
* valid driving license
* male and female
* right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
* capability to walk with or without a walking stick

Exclusion Criteria:

* myocardial infarction/Apoplexia \< 6 months
* Total knee arthroplasty \<5 weeks
* New York Heart Association 3/4
* lacking drivers' license
* peripheric sensomotor deficit \<3/5 British Medical Research Council
* new fracture of the lower extremity or spine
* systemic or metastasised Cancer
* drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)
Intravitreal Aflibercept for Therapy of Patients With Pseudoxanthoma Elasticum (PXE)

The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the treatment of choroidal neovascularization and fibrovascular proliferation in patients with pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PXE by moleculargenetic diagnosis and/or skin biopsy
* Diagnosed CNV or FVP
* Age 18-65 years
* Voluntary participation in this study as proven by written informed consent
* Ability to follow study instructions and likely to attend and complete all required visits
* Best corrected visual acuity between 20/400 and 20/20 at treated eye
* Male and female patients with childbearing potential must use an approved contraceptive method (Pearl Index \< 1) before and during the trial
* Pre-menopausal female patients with childbearing potential: a negative pregnancy test must be obtained

Exclusion Criteria:

* Subject is unable to understand the nature, scope, significance and consequences of this clinical trial
* Patients with known allergy or hypersensitivity to Eylea or preparations with similar chemical structure
* Treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial of within 30 days before enrolment
* Known or persistent abuse of medication, drugs or alcohol
* Women who are pregnant or breast feeding
* Lack of eligibility at discretion of the investigator
* Ocular operations within a month prior to enrolment
* Non-controlled glaucoma
* Active intraocular inflammation or inflammation of ocular adnexa
* Other diseases resulting in distinct visual constraint
* Distinct opacification of optical media
* Distinct subretinal fibrosis and /or atrophy that prevents a relevant treatment effect by Aflibercept at discretion of investigator
* Serious cardiovascular problems or stroke within 6 months before enrolment
* Simultaneous use of other Vascular Endothelial Growth Factor (VEGF)-inhibiting medication (systemic or ocular) within a month prior to enrolment
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors

This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.

Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Recurrent or metastatic cancer, including lymphoma.

No leukemia.

No active CNS disease.

Refractory to all effective therapy OR No effective therapy exists.

Measurable disease not required.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy.

Chemotherapy: Greater than 4 weeks and recovered from chemotherapy.

Previous therapy with irinotecan is permitted.

Endocrine Therapy: Not specified.

Radiotherapy: Greater than 4 weeks since radiotherapy.

Surgery: Recovered from prior surgery.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0-2.

Hematopoietic: AGC greater than 1,500.

Platelets greater than 100,000.

Hepatic: Bilirubin no greater than 1.5 mg/dL.

AST no greater than 2 times normal.

Renal: Creatinine no greater than 1.5 mg/dL.

OTHER:

HIV negative.

No active infection requiring antibiotics.

No concurrent medical illness that would interfere with chemotherapy.

No pregnant or nursing women.

Adequate contraception required of fertile patients.

Imaging/exams for tumor measurement within 28 days prior to registration.
Perioperative Outcome Risk Assessment With Computer Learning Enhancement

This study will test whether anesthesiology clinicians working in a telemedicine setting can predict patient risk for postoperative complications (death and acute kidney injury) more accurately with access to a machine learning display than without it.

The Perioperative Outcome Risk Assessment with Computer Learning Enhancement (Periop ORACLE) study will be a sub-study nested within the ongoing TECTONICS trial (NCT03923699). TECTONICS is a single-center randomized clinical trial assessing the impact of an anesthesiology control tower (ACT) on postoperative 30-day mortality, delirium, respiratory failure, and acute kidney injury. As part of the TECTONICS trial, investigators in the ACT perform medical record case reviews during the early part of surgery and document how likely they feel each patient is to experience postoperative death and acute kidney injury (AKI). In Periop ORACLE, these case reviews will be randomized to be performed with or without access to machine learning (ML) predictions.

Investigators in the ACT will conduct all case reviews by viewing the patient's records in AlertWatch (AlertWatch, Ann Arbor, MI) and Epic (Epic, Verona, WI). AlertWatch is an FDA-approved patient monitoring system designed for use in the operating room. The version of AlertWatch used in this study has been customized for use in a telemedicine setting. Epic is the electronic health record system utilized at Barnes-Jewish Hospital. Each case review will be randomized in a 1:1 fashion to be completed with or without ML assistance. If the case review is randomized to ML assistance, the investigator will access a display interface (currently deployed as a web application on a secure server) that shows real-time ML predicted likelihood for postoperative death and postoperative AKI. If the case review is not randomized to ML assistance, the investigator will not access this display. After viewing the patient's data, the investigator will predict how likely the patient is to experience postoperative death and postoperative AKI and will document this prediction. The area under the receiver operating characteristic curves for predictions made with ML assistance and without ML assistance will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Surgery in the main operating suite at Barnes-Jewish Hospital
* Surgery during hours of ACT operation (weekdays 7:00am-4:00pm)
* Enrolled in the TECTONICS randomized clinical trial (NCT03923699)

Exclusion Criteria:

* None
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses

Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be current soft lens wearers in both eyes.
* Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
* Either gender
* Any racial or ethnic origin

Exclusion Criteria:

* Participants cannot be pregnant or lactating.
* Participants cannot be current wearers of the study lenses
* No current ocular inflammation or infection as assessed by the study investigator
SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.

Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.

Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female \>/= 18 years
* Diagnosis of small cell lung cancer
* Patient newly diagnosed with SCLC
* Has given written informed consent (if applicable)

Exclusion Criteria:

* Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
* Patient presenting with recurrence of SCLC.
* Patients who has received any chemotherapy for the SCLC.
Pain Sensitivity in Acute Inflammatory Pain

Pain is a complex experience influenced by gender and genetics, and, by psychosocial and sensory experiences. Pain sensitivity is thus highly variable between individuals.

In the present study we evaluate individuals´ pain perception in response to a number of different pain stimuli in 100 healthy volunteers (50 females and 50 males).

The data will allow us to assess pain sensitivity, to predict pain responses and to investigate gender related differences in pain perception.

A second aim is to evaluate the robustness of the different pain-tests since the tests are repeated with an interval of 2-4 weeks.

Pain perception is affected by physiological, psychological, existential and demographic factors.

In the present study psychophysiological, psychological, genetic and demographic components in pain perception are evaluated in healthy volunteers (n = 100).

Psychophysical assessments following induction of a first degree burn injury (47.0 C, 420 s, 12.5 sq.cm, lower leg) include:

* pain during induction of burn injury
* thermal thresholds
* tactile thresholds
* electrical thresholds
* areas of secondary hyperalgesia
* pressure algometric assessments
* assessment of Diffuse Noxious Inhibitory Control (DNIC) efficiency
* assessment of (DNIC) using cold pressor test

Psychological assessments include:

* HADS (Hospital Anxiety and Depression Scale)
* PCS (Pain Catastrophizing Scale)
* vulnerability score

Genetics include:

- A118G SNP

Demographics include:

* gender
* height
* weight

Eligibility Criteria:
Inclusion Criteria:

* healthy
* psychomotor ability to perform the tests
* cognitive ability to perform the tests

Exclusion Criteria:

* smoker
* Body Mass Index \> 28
* participation in drug studies \< 4 weeks prior to inclusion
* chronic pain
* chronic intake of analgesics
* drug or alcohol abuse
* intake of analgesics \< 48 hours prior to study
* females not on contraceptive therapy (intra-uterine device or p-pill)
* lesion in the assessment area
Prognostic Value of Stem Cell Related Markers

The goal of the investigators study is to identify a prognostic marker that will evaluate the probability of recurrence in patients with stage 0-II breast cancer following surgery to remove the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Ductal Carcinoma in Situ
* DCIS + Microinvasion stages 1 or 11 without positive lymph nodes

Exclusion Criteria:

* tumor specimen with higher than grade II
* BRACA 1 or BRACA 2 mutation
* Neoadjuvant chemotherapy
Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort

The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.

The primary objective of this study is to assess the impact of a combined protocol of subanesthetic ketamine infusions (SKI) and bilateral cervical sympathetic blocks (CSB) on aging, as measured by the GrimAge epigenetic clock.

The secondary objective of this study is to assess the impact of this treatment paradigm on PTSD and mental health, as measured over a 6 month time period using the following questionnaires: Post-traumatic Stress Disorder Checklist (PCL-5), Patient Health Questionnaire 9 (PHQ-9), Depressive Symptom Index-Suicidality Subscale (DSI-SS), Generalized Anxiety Disorder 7-item (GAD-7), and Neurobehavioral Symptom Inventory (NSI).

The tertiary objectives of the study are to investigate if PTSD is associated with significantly reduced free testosterone levels and increased C-reactive protein (CRP) levels.

Eligibility Criteria:
Inclusion Criteria:

* Recruited from SOF with an active duty history of at least 5 years.
* Subjects may be in active duty or retired, male and female, between the ages of 40 and 60 years old.
* The participants must have a confirmed diagnosis of PTSD, identified by Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores higher than 40.
* The participants must have been on a stable pharmacological or psychotherapeutic therapy for at least three months (if applicable), and continue this treatment throughout the duration of the study.
* They must be able and willing to consent for the study. Individuals who are able to become pregnant must adhere to a medically accepted method of contraception (eg. hormonal birth control, barrier birth control, intrauterine device, abstinence).

Exclusion Criteria:

* Existing Horner syndrome;
* Allergy to local anesthetics or contrast;
* Previous history of stellate ganglion block with psychosis;
* Admission to in-patient psychiatric facility within last 3 months;
* History of moderate of severe TBI;
* Currently pregnant or breastfeeding;
* Current substance use disorder, or test positive for 1 or more illegal or controlled drugs on the initial urine drug screen, such as cocaine, marijuana, amphetamines, opioids, benzodiazepines, amongst others;
* Previous behavioral health diagnoses (bipolar I, psychosis, etc);
* Currently undergoing exposure therapy.
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.

Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States.

Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery

There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

Risankizumab-Exposed Cohort

* US resident.
* Current pregnancy.
* Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
* Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).

Diseased Comparison Cohort

* US resident.
* Current pregnancy.
* Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
* Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).

Exclusion Criteria:

Risankizumab-Exposed Cohort

* Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
* Occurrence of pregnancy outcome prior to enrollment in the registry

Diseased Comparison Cohort

* Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
* Occurrence of pregnancy outcome prior to enrollment in the registry
Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery

This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction.

Natural Orifice Specimen Extraction (NOSE) in colorectal surgery allows the extraction of the surgical specimen through the anal orifice. Several studies demonstrated improved postoperative pain, bowel movements, patient-reported cosmetic satisfaction, and psychological wellbeing after NOSE compared with traditional Pfannenstiel extraction. However, most of these studies focused on colon surgery. The aim of this retrospective propensity score matched study is to investigate the postoperative outcomes of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer between January 2017 and January 2023
* Patients with rectal cancer classified as "low" according to the English National Low Rectal Cancer Development Programme (LOREC)

Exclusion Criteria:

* Patients undergoing non-restorative procedures
* Patients undergoing immediate or delayed handsewn coloanal anastomosis
* Patients undergoing planned open surgery or unplanned conversion from minimally invasive to open surgery
* Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD)
Scleroderma Treatment With Celution Processed ADRCs Registry

This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.

This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of scleroderma and presence of hand scleroderma
* Cochin score ≥ 20 units

Exclusion Criteria:

* Body Mass Index \< 17 kg/m2
* Infection in any finger
* Stable medications for the treatment of scleroderma for ≥ 1 month
* Pregnant or lactating status.