cyrilzakka/clinical-trials huggingface dataset:
Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease

The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD).

Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD.

New research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels.

In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD.


Eligibility Criteria:
Inclusion Criteria:

* Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D \< 30 ng/ml), and with absolute iron deficiency (TSAT \< 20 and Ferritin \<100) or iron restriction (TSAT \< 20 and Ferritin \> 100).

Exclusion Criteria:

* Active vitamin D analog therapy or history of recent (\< 3 months) use.
* Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day.
* Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy.
* Oral iron therapy started within the last 3 months.
* Hb \< 8.0 g/dL for males and Hb \<7.0 g/dL for females.
* Pregnancy or lactation.
* Serum calcium \> 10.0 mg/dL or phosphorus \> 4.5 mg/dL.
* Subjects with acute kidney injury or rapidly declining GFR.
* Subjects on hemodialysis, peritoneal dialysis, or having a functioning renal transplant.
* Focus of active inflammation such as acute gout, rheumatoid arthritis or active infection determined clinically.
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects

The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects intolerant to statins.

In humans, apoB is the principal apolipoprotein of the atherogenic lipoproteins, comprising very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL) and low density lipoprotein (LDL). ApoB messenger ribonucleic acid (mRNA) is abundantly present in the liver. Within the endoplasmatic reticulum, apoB requires lipidation by microsomal triglyceride transfer protein, which allows apoB to be incorporated in the VLDL particle within the lumen of the endoplasmatic reticulum. Non-lipidated apoB is readily degraded via ubiquitination. Notably, apoB within the VLDL particle is obligatory for hepatic secretion of VLDL. ApoB remains present within the VLDL-metabolism pathway, from secretion to clearance of the end product LDL by the liver LDL receptor. As a consequence, apoB reliably reflects the total burden of atherogenic lipoproteins. Thus, apoB carries strong prognostic value for cardiovascular events, which exceeds the predictive value of LDL-C. Conversely, decreased levels of apoB (e.g. in familial hypobetalipoproteinemia) have been associated with reduced levels of atherosclerosis. These genetic observations have prompted interest in pharmacologic inhibition of apoB synthesis.

Mipomersen (ISIS 301012) is an antisense drug targeted to human apoB, the principal apolipoprotein of LDL and its metabolic precursor, VLDL. Mipomersen (ISIS 301012) is complementary to the coding region of the mRNA for apoB, binding by Watson and Crick base pairing. The hybridization (binding) of mipomersen (ISIS 301012) to the cognate mRNA results in Ribonuclease (RNase) H-mediated degradation of the cognate mRNA, thus inhibiting translation of the apoB protein.

This was a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety and efficacy of mipomersen administration in high-risk statin-intolerant patients with hypercholesterolemia. This study consisted of a ≤3-week screening period, 26 weeks of treatment, and a 24-week post-treatment follow-up period.

Eligible patients were randomized in a 2:1 ratio to receive mipomersen 200 mg or matching volume placebo subcutaneous (SC) injections weekly.

Following the screening visit, eligible patients returned to the study center for clinical evaluation every week for study drug administration and assessments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of statin intolerance
* Diagnosis of Coronary Artery Disease (CAD)
* Diagnosis of hypercholesterolemia
* Stable weight for \> 6 weeks

Exclusion Criteria:

* Significant health problems in the recent past (≤24 weeks) including heart attack, heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive problems, disease of central nervous system, cancer, liver or renal disease
Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence

Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent keloid at site of surgical scar. One group will undergo surgical excision of keloid. The other group will have combined surgical excision of keloid and single intralesional dexamethasone injection at edges of wound.All patients were reviewed once per month for 6 months for evidence of recurrence

One hundred forty six patients that are admitted at Kasr Al Aini teaching university hospital for caesarean section, will be enrolled in this randomized clinical trial after approval by the local ethical health committee. A written informed consent will be obtained from each participant after full explanation of the procedure.

Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of the keloid is performed and minimal undermining followed by the usual steps of caesarean section. Primary closure of the wound in layers is achieved in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A of 73 patients will not receive further injection. In 73 patients (group B), the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.

For all patients, the wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed.

Postoperative medications are given to all patients in the form of analgesics and antibiotics as routinely given at the hospital. All patients were advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) were used in any of the patients. All patients were reviewed once per month for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Documented keloids of pfannenstiel incision or midline subumbilical incision of one to five years duration.
* Previous treatment of keloid and recurrence.
* Patient complaint of cosmetic disfiguring, pain or pruritis at site of scar.

Exclusion criteria:

* Scar \<1 years' duration
* Scar extending beyond the limits of the original lesion
* postburn keloids
* Diabetes Mellitus, anaemia (haemoglobin level \<10mg/dL), malignancy, malnutrition.
* local inflammation at site of scar
* Allergy to dexamethasone.
* Immunocompromized patients or patients on chronic steroid treatment.
Compassionate Communities Neighbourhood Program

This study will evaluate a Compassionate Communities-based intervention aimed at reducing social isolation by mobilizing individuals to act on their health and social needs individually, and in collaboration with fellow members of their community. The intervention program includes facilitated building of neighbourhood networks (member benefits include access to practical help, the opportunity to develop meaningful relationships, and community mobilization), and coaching support to work on individualized goal setting and more detailed navigation support and planning.

The Compassionate Communities intervention is catalyzed by professional facilitators who visit communities with high concentrations of elderly and vulnerable residents, and recruit those who are interested in a project to identify their own health and social needs, assets and priorities; to collectively work to support each other in achieving these; and to implement a neighbourhood exchange to more easily match offers of help to people who need help. The mobilization work starts with the facilitator, who is employed by a community or social service organization, but increasingly draws on the energies of the mobilized initial participants as volunteers who conduct further community outreach in their community, attracting and mobilizing other residents, peers, and neighbouring resources in the work. Participants also plan and implement a broad range of activities identified by the residents as their priorities for neighbourhood building. Participants and their caregivers have the option of receiving more in-depth 1:1 coaching support to work on individualized goal setting, more detailed navigation support or advanced care planning following the sessions.

Eligibility Criteria:
Inclusion Criteria:

* Seniors (65 years of age and older)
* people with disabilities
* caregivers of seniors or people with disabilities
* residing in identified buildings/ neighbourhoods where the WECCC Compassionate Communities Neighbourhood program is being launched
* able to communicate in English or interpreter can be arranged

Exclusion Criteria:

* not able to communicate in English and interpreter cannot be arranged
The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms on US Veterans

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.


Eligibility Criteria:
Inclusion Criteria:

* Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics
* Skin type must be "Fair", Fitzpatrick type I or II, due to the presence of actinic damage in this population.
* Subjects must have a VA physician's order to receive PDT treatment on their forearms.
* Willing to participate and understand the informed consent document.
* Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT.
* Has stable transportation to attend study visits at DVA

Exclusion Criteria:

* Currently taking any tricyclic antidepressants (TCAs)
* Currently taking any selective serotonin reuptake inhibitor (SSRI)
* Has Porphyria
* Large tattoos in areas to be tested
* Pregnancy or nursing
* Taking any oral or topical medications that could interfere with the PDT
* Active rashes in the areas
Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women

The purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (CVD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing CVD as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol (\>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat level before you start training and after 15 and 30 weeks of training in the form of walking. At the present time the effects of exercise intensity on these factors are not well understood. This study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing CVD.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal and preferably on hormone replacement therapy
* In good general health
* Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40
* Exercise less than 20 min/day two days a week
CtDNA-Directed Post-Hepatectomy Chemotherapy for Patients with Resectable Colorectal Liver Metastases

To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.

Primary Objective:

• To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy

Secondary Objectives:

* To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients
* To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients
* To evaluate the proportion of ctDNA-negative at 1-year post-resection
* To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls
* To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement
* To delineate the pattern of disease recurrence
* To assess ctDNA sensitivity and specificity for predicting disease recurrence
* To evaluate MDASI-GI during the course of postoperative therapy
* To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection
* To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy

Outcome Measures:

Primary:

• Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients

Secondary:

* Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients
* Overall survival (OS) among ctDNA-negative and ctDNA-positive patients
* ctDNA-negativity at 1-year post-resection
* Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics
* Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable)
* ctDNA sensitivity/specificity for recurrent disease overall by timepoint
* MDASI-GI at clinic visits during course of postoperative therapy
* Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection
* Adverse events

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023
* Must receive ≥ 4 cycles of preoperative chemotherapy

Exclusion Criteria:

* Patients with primary colorectal tumor that will remain in situ
* Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
* Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
* Other active malignancies requiring treatment
* Women who are pregnant
Jailed-balloon Technique in Coronary Bifurcation Lesion PCI

This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).

1. Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
2. Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
3. Study design: This is a multi-center, prospective, randomized study.
4. Methods

4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.

4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) \>2.5mm while side branch \<2.5mm and \>1.5mm;
3. Only one bifurcation lesion need to be treated in one vessel;
4. The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%;
5. Signed consent is obtained.

Exclusion Criteria:

1. Left ventricular ejection fraction(LVEF) less than 30%;
2. Hemodynamic instability or cardiac shock;
3. Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
4. Tumor with expected survival less than 1 year;
5. Autoimmune disease;
6. Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
7. Acute coronary syndrome require emergency PCI;
8. Coronary bifurcation need to be treated with two-stent strategy;
9. Not suitable for drug-eluting stent(DES) implantation;
10. Mental disorder or alcohol dependence;
11. PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;
12. Target lesion is in-stent restenosis;
13. Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes

This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).

The potential candidates for the study are patients scheduled for primary TKA. Scheduled patients will be sent an invitation letter detailing the study's objectives and design. Should they choose to take part, individuals will be requested to utilize MyChart for the completion of PROMs. The information gathered from these PROMs will play a pivotal role in assessing their suitability for inclusion in the study. Subsequently, once deemed eligible, our coordinator will arrange a convenient session to meticulously review and facilitate the signing of the informed consent form (enrollment visit). This enrollment visit will take place approximately 2-3 months prior to the scheduled surgery. Subsequently, enrolled patients will be randomized in a 1:1 ratio to:

i) Standard of Care ii) Standard of Care + TKA Personalized Outcome Prediction Tool (Mental Health Screening/Intervention \& Physical Therapy Pre-surgery Assessments/Intervention)

TKA Personalized Outcome Prediction Tool aids in setting expectations for surgery and the results (calculated from patient information and baseline PROMs) will be provided and discussed with the patients by the surgeon.

The primary outcome of the study will be the proportion of patients who fail treatment, defined as patients who answer "no" to the PASS anchor question at 1-year postoperative. The treatment and control groups will be compared using a chi-square test between the randomized groups with p=0.05 as the threshold for statistical significance. We will follow the intent-to-treat principle, and patients assigned to the treatment/intervention arm will be analyzed as such regardless of his/her compliance with the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subject (Age \>18 and \< 80 years of age)
2. The subject is proficient in the English language
3. The patient is voluntarily prepared to sign the 'Informed Consent Form'
4. The patient is scheduled for a unilateral primary TKA
5. TKA PROMs Phenotypes with higher risk of dissatisfaction
6. Patient is willing and able to complete the protocol required follow-up

Exclusion Criteria:

1. Patient requires simultaneous or staged bilateral knee replacements, staged \<90 days apart
2. Patients undergoing revision TKA
3. Inflammatory arthritis
4. History of infection in the joint undergoing TKA
5. Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Evaluation of Virtual Reality Headsets on Cancer Patients During Day Hospital Stay

Use of virtula reality headsets during treatment course on day hospitalized cancer patients


Eligibility Criteria:
Inclusion Criteria:

* cancer patients
* chemotherapy treatment

Exclusion Criteria:

-