cyrilzakka/clinical-trials huggingface dataset:
PROs Following Low-dose Irradiation for Osteoarthritis

The goal of this observational registry study is to collect data related to patient reported outcomes (pain, function, quality of life, toxicity) in osteoarthritis (OA) patients receiving standard of care radiation therapy (RT).

This is a single-institution, single-arm, prospective, observational study of patients with osteoarthritis who are being treated with standard of care radiation therapy (RT). The purpose of this non-interventional study is to systematically collect data related to patient reported outcomes (pain, function, quality of life, toxicity) with the goal of optimizing approaches to management with radiation therapy and clinical care during follow up. The primary endpoint of this study is a change in visual analog pain scale (VAPS) at 3 months post radiation and a variety of secondary endpoints are aimed at assessing disease control, patient function, avoidance of invasive surgery, and toxicity. Participants will complete patient-reported outcome surveys for pain and joint-specific functional assessment.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Established diagnosis of OA of at least 1 joint
* Inadequately controlled pain due to OA despite attempts with 2 or more other treatment modalities and Visual Analogue Pain Score of 4 or greater.
* Will undergo radiation as part of their standard of care for OA.
* At least 55 years old
* Ability to read and speak English.

Exclusion Criteria:

* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-HCG results, obtained within 2 weeks of CT simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses).
* Estimated life expectancy less than 6 months.
* Radiation treatment for shoulder OA
* Patient weight greater than 550lbs
Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema

Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion for a fracture AND
* indication for CT confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* cardiorespiratory instability (as judged by the referring physician)
* age \< 18 years
* known or suspected pregnancy
* known bone metastases of a malignant disease
* known rheumatic disease
* metal implants in the region to be scanned
* surgical intervention over the last 12 months in the region to be scanned
* contraindications for MRI
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)

Multiparametric MRI (mpMRI) of the prostate is an important tool for diagnosis of clinically significant prostate cancer (csPCa) in men with an elevated serum prostate specific antigen, which can decrease the rate of unnecessary biopsies and reduce the incidence of over-diagnosis of non-csPCa. Furthermore, there is evidence that MRI is more accurate in detecting high-grade (Gleason grade group ≥3) versus low grade cancers (Gleason grade group \<2) and therefore may serve as a useful adjunct to prostate-specific antigen (PSA) testing, digital rectal examination, and prostatic biopsy to detect cancers that require definitive treatment as opposed to active surveillance. Many investigators, including our group, have shown the utility of preoperative mpMRI to assess the local extent of prostate cancer and for surgical planning.

Primary Objective:

To compare the detection rate of Gleason Group grade ≥ 2 disease in patients with intermediate and high-risk prostate cancer who undergo ERC mpMRI (Group 1: Control) versus patients who undergo non-ERC mpMRI with flexible AIR coil technology (Group 2: Experimental).

Secondary Objective:

1. To compare the scanning time and room time in Group 1 versus Group 2.
2. To compare patient-reported outcome at the end of the MRI test in Group 1 versus Group 2 through testing morbidities index (TMI).
3. To determine the impact of mpMRI on treatment planning for men with intermediate and high-risk prostate cancer and compare management impact in Group 1 versus Group 2
4. To compare the detection rate of T3 disease on MRI (confirmed by histopathology) at prostatectomy between Group 1 versus Group 2.

Eligibility Criteria:
Inclusion Criteria:

* Male, Age ≥ 18
* Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade \>/=2) adenocarcinoma of the prostate
* Patient is being considered for curative-intent treatment with radical prostatectomy within 6 months following mpMRI
* Patient has provided written informed consent for participation in this trial
* Patient should be eligible for scanning at 3 T magnet

Exclusion Criteria:

* Low-risk adenocarcinoma of prostate
* Patient has had any prior therapy for prostate cancer
* A history of other active malignancy within the last 2 years
* Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
* Cardiac pacemaker
* Orthopedic hardware in the pelvis and spine.
* Claustrophobia and/or receiving anesthesia
* Contraindication for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, and lack of rectum.
Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis

The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.


Eligibility Criteria:
Inclusion Criteria:

* Men/Women
* Age between 18 and 45 years
* Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

Exclusion Criteria:

* Smoke
* Any chronic disease
* Intake of nutritional or ergogenic supplements
* Chronic medication
* Cocoa allergy
Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)

Background: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years.

Beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty. Animal data and human data suggests that beta blockers reduce portal pressure in patients with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till date.

Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with NCPH.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy

Exclusion Criteria:

* A history of surgery for portal hypertension
* Patients already on a EST, EVL, or glue injection program before presenting to our hospital
* Patients already on beta blockers for primary prophylaxis of variceal bleed
* Severe cardiopulmonary or renal disease
* Bradycardia (basal heart rate, \<50 beats per minute \[bpm\]) or complete heart block
* A history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure \<90 mm Hg)
* Refusal to give informed written consent to participate in the trial
* Patients bleeding from gastric varices or Portal Hypertensive Gastropathy (PHG).
* Patients who had a failure of primary hemostasis during acute bleed were also excluded.
Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.

There would be two comparison groups. Current standard of care treatment at PKLI\&RC (as per local guidelines) would be given to all patients receiving TACE for the intervention group or 'antibiotic group' (i.e., Inj. Ceftriaxone 1g, intravenous × stat). While no antibiotic would be given to the 'no antibiotic group'.

Liver cancer especially hepatocellular carcinoma (HCC) is among the top five most common carcinomas in the world. According to the latest Cardiovascular and Interventional Radiological Society of Europe (CIRSE) standards of practice guidelines (2021), routine antibiotic prophylaxis is not recommended. However, prophylactic antibiotics are recommended in cases where there is a high risk of developing a liver abscess. These include biliary obstruction or the presence of a bilioenteric anastomosis. This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary liver cancer or hepatocellular carcinoma.
2. Patients receiving TACE in PKLI \& RC.
3. Patients giving informed consent.

Exclusion Criteria:

1. Receiving two or more TACE during the same hospitalization
2. Use of any antibiotics other than the prophylactic antibiotic in 48hours prior to TACE
3. Known hypersensitivity to specified antibiotic used in the study
4. Incomplete or missing laboratory investigations and data
5. Taking Sorafenib before TACE
6. TACE combined with ablation or immunetherapy
7. Tumor size \>10 cm
8. Portal vein thrombosis
9. Dilated biliary channels on CT scan / Billiary invasion by tumor
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).

The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (\<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years
* skeletally mature
* Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
* Functional meniscal tissue (defined as 5 mmor greater)
* A score of = or greater than 4 on the VAS questionnaire

Exclusion Criteria:

* Associated tibial or patellar articular cartilage defect greater than 2 ICRS
* Osteoarthritis of either knee
* Mechanical axis malalignment of greater than 5 degrees
* Patellofemoral incongruity on Merchant view
* One or more multiple defects greater than 2.5 cm
* Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
* Ligament treatments in the affected knee within one year prior to current study
* Previous surgical meniscus treatment in the affected knee in the last 6 months
* Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
* use of any investigational therapy within 30 days prior to the first visit
* Corticosteroid or viscosupplementation within the past 3 months
* A score of 3 or less on the VAS questionnaire
* Active gout or pseudogout or systemic inflammatory condition
* Microfracture less than one year prior to current study
Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients

Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.

Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Background

Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.

Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Study Population

Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects

Randomization

Patients will be randomized to receive for 6 months either ezetimibe (10 mg/day) or a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg).

Eligibility Criteria:
Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Recent (\<12 months) percutaneous coronary intervention
* Class I indication to receive statin treatment
* Previous (\<12 months) withdrawn of a statin due to side effects
* Unwilling to receive treatment with an alternative statin
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Mindfulness and Hip Preservation Surgery

Hip preservation surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting effects such as muscle weakness or diminished joint function, hip pain, and fear. Many of these patients report greater anxiety and depression following surgery, which can further compound negative outcomes in these patients. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following hip preservation surgery.

The goal is to identify whether a mobile-based daily mindfulness program for the immediate eight weeks following hip preservation surgery improves outcomes in patients. The investigators hypothesize that patients who participate in a mindfulness intervention will have less pain, better hip function, greater quality of life, and improved scores on standardized patient reported outcome measures for 24 months following surgery.

The investigators expect their findings will re-direct post-operative strategies beyond the physical recovery in orthopedic surgery patients and improve long-term outcomes. To test the overall hypothesis and contribute significantly to understanding of the impact of a psychosocial intervention on outcomes in orthopedic surgery patients, the specific aim is to determine the influence of mindfulness training on patient-reported outcomes following hip preservation surgery.

* Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes following hip preservation surgery

  * Hypothesis 1: Mindfulness training will be associated with improvements in pain, post-operative opiate use, hip function, quality of life and improved scores on standardized patient reported outcome measures for 24 months following hip preservation surgery
* Specific Aim 2: To determine the factors that influence mindfulness efficacy in patient-reported outcomes following hip preservation surgery

  * Hypothesis 2: Among participants in the mindfulness group, total duration of mindfulness training, female gender, and higher education level will be independently and positively associated with improvements in pain, hip function, and quality of life for 24 months following hip preservation surgery

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old at the time of the pre-operative visit
* Access to a mobile device compatible with the freely available Healthy Minds Program (HMP) App (Android or iOS)
* Participation in study 2019-0363

Exclusion Criteria:

* Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc).
* Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year
Cooking for Health

Type 2 diabetes is a leading cause of morbidity and mortality among American Indians (AIs) in the United States. Although healthy diet is a key component of diabetes management programs, many AIs face barriers to adopting a healthy diet including: difficulty budgeting for food on low-incomes, low literacy and numeracy when purchasing food, and limited cooking skills. The proposed project will evaluate a culturally-targeted healthy foods budgeting, purchasing, and cooking skills intervention aimed at improving the cardio-metabolic health of AIs with type 2 diabetes who live in rural areas.

The research activities proposed in this application address a pressing need in American Indian (AI) communities - the evaluation of a culturally-tailored healthy food budgeting, purchasing, and cooking intervention to see whether it can improve diet and health among AIs with type 2 diabetes.

This randomized clinical trial will compare the efficacy of a culturally-tailored healthy food budgeting, purchasing, and cooking program on: (1) diet quality (i.e., intake of sugar-sweetened beverages, processed foods) and (2) healthy food budgeting and cooking skills, among AIs with type 2 diabetes who reside in a large AI community in the north-central United States. Additionally, the investigators will conduct a mixed methods process evaluation to assess intervention reach, fidelity, and participant satisfaction. Curriculum will be tailored to an AI population with diabetes, and directly address major barriers to healthy eating that were identified by community members and tribal leaders in recent focus groups including: (1) difficulty budgeting for food on low-incomes; (2) low literacy and numeracy when purchasing food (e.g., inability to use in-store scales to convert foods priced "per pound" to dollar values); (3) limited cooking skills. The investigators expect that implementation of a culturally-tailored diet intervention will be effective in promoting positive diet change, and increase healthy food budgeting and cooking skills.

Poorly controlled diabetes affects the health/longevity of those afflicted, and has profound effects on healthcare costs. Greater efforts are needed to encourage healthy eating in underserved communities with a high burden of diabetes. Improving healthy food budgeting, purchasing, and cooking skills among AIs with diabetes should improve diet and diabetes management. If successful, this program can be extended to other AI communities.

Eligibility Criteria:
Inclusion Criteria:

* American Indian
* 18+ years
* self-reported type 2 diabetes
* reside on reservation where study is being conducted
* self-identify as person who holds most of the responsibility for household budgeting, shopping, and cooking

Exclusion Criteria:

* pregnant
* history of bariatric surgery
* chronic kidney disease
* on dialysis
* cognitively impaired
* individuals without a reliable place to cook or store food (e.g., homeless)
Ponatinib in CML Patients in Chronic Phase

The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP).

In particular, the aims of the study will be:

* primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers;
* secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy).

The study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.

The study protocol is a non-interventional, retrospective observational study which involves the collection of data from medical records relating to the plasma dosages of ponatinib performed as per clinical practice, all carried out at the pharmacokinetics laboratory of the U.O. Clinical Pharmacology and Pharmacogenetics of AOUP. These data will be collected in CRF and will be correlated to efficacy data (extent of molecular response) and toxicity of ponatinib (haematological, extra-haematological adverse events, together with adverse event severity). Real-life experience (dosage adjustments made by clinicians based on plasma dosage) will be used to propose an algorithm that can help in choosing the correct dosage of ponatinib.

Classical statistical analyses (for descriptive and comparison aims) will be used according to their appropriateness. Moreover, factors affecting the pharmacokinetics of ponatinib will be investigated by nonlinear mixed effect modeling adopting the MONOLIX 2021R2 suite. Final model will be used as parte of the dosing algorithm.

Notably, all clinical and laboratory data will be anonymized to protect patients' privacy, and harvested in a database that will be used to perform pharmacometric and statistical analyses.

Eligibility Criteria:
Patients will be enrolled according the following inclusion criteria:

* Subjects ≥18 years old affected by CML
* Patients being treated with ponatinib at a dose of 45, 30 or 15 mg/day for more than 14 days
* Patients who have provided informed consent to the study

Exclusion criteria:

* Subjects \<18 years old
* Patients who did not provide an informed consent to the study

The co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib PK variability.