cyrilzakka/clinical-trials huggingface dataset:
Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease

The goal of this pilot study is to evaluate the feasibility of administering niacinamide to patients with autosomal dominant polycystic kidney disease, to develop methods to assess the biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical effect on kidney cyst growth and kidney function.

Niacinamide is a form of vitamin B3. Vitamin B3 is found in many foods including yeast, meat, fish, milk, eggs, green vegetables, beans, and cereal grains. Recent studies in mice have shown that niacinamide, at high doses, may slow kidney cyst growth from polycystic kidney disease (PKD).

By doing this study, the researchers will determine if a larger, long-term study to test whether niacinamide slows progression of PKD is justified.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of autosomal dominant polycystic kidney disease
* eGFR \> 90ml/min/1.73m2 as determined from the serum creatinine by the CKD-EPI equation
* Ability to give informed consent in English

Exclusion Criteria:

* History of liver disease or abnormal liver function test
* Heavy alcohol intake
* Chronic diarrhea or malabsorption syndrome
* Thrombocytopenia
* Hypophosphatemia
* Pregnancy or lactation or plan to become pregnant during the study
* Treatment with anti-epileptic drugs
* Treatment with tolvaptan, current or within 2 months prior to screening
* Participation in another interventional trial currently or within 30 days prior to screening
* Partial or total nephrectomy or renal cyst reduction (including aspiration) done \<1 year ago
* Cardiac pacemaker
* Presence of magnetic resonance-incompatible metallic clips (e.g. clipped cerebral aneurysm)
* Body weight \>159 kg (350 lbs) or untreatable claustrophobia
PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.


Eligibility Criteria:
Inclusion Criteria:

1. Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
2. Patients who are willing and able to undergo the study procedures
3. The patient has provided personally written informed consent

Exclusion Criteria:

1. Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging
2. Patients with clinically positive axillary lymph nodes
3. Age \< 18 years
4. Inability to provide informed consent
5. Pregnancy
6. Weight \>100 kg (because of the format of the PET/MRI scanner)
7. General contraindications for MRI (such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia) or PET (i.e. known allergy to 18F-FDG)
8. Hyperglycaemia (\> 11 mmol/L) at the time of 18F-FDG injection
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
* Location of the tumor, posterior to the equator of the eye.
* Documented growth of tumor by A-B scan.
* Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion Criteria:

* Pregnancy or lactation.
* Premenopausal women not using adequate contraception.
* Current infection or inflammation in either eye.
* Extension of tumor into the orbit.
* Regional spread or metastatic disease.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Any known allergy to any of the components to be used in the study.
* Participation in another simultaneous medical investigation or trial.
A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function

This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.

PRIMARY OBJECTIVES:

I. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and quality of life as measured by the LymQOL-midline.

II. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and DASH measure of shoulder function.

III. Determine how the presence of chest wall lymphedema as determined by physical exam may affect an individual's quality of life as measured by the LymQOL-midline assessment.

IV. Determine how the presence of chest wall lymphedema as determined by physical exam may shoulder function on the effected side, as measured by the Disabilities of the Arm, Shoulder, and Hand questionnaire.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo chest wall and breast lymphedema measurements by clinical assessment and using the Delfin Moisture Meter D Compact and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Women of any age with diagnosis of any type of breast cancer

  * Breast cancer on unilateral or bilateral side
  * Surgical intervention for treatment of breast cancer

Exclusion Criteria:

* Previous shoulder injury or known shoulder limitation on affected side
Brief Mindfulness Intervention for Orthopedic Patients

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Seeking foot or ankle treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

* • Cognitive impairment preventing completion of study procedures.

  * Current cancer diagnosis,
  * Other unstable illness judged by medical staff to interfere with study involvement.
Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream

This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy subjects aged 18-64 years (inclusive).
* Fitzpatrick skin type of I, II, or III.

Key Exclusion Criteria:

* Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes or dense body hair in the range of the test fields.
* Any history of or presence of cancerous or precancerous skin lesions.
* Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
* Known disease that can be induced by ultraviolet (UV) light.
* Use of any topical or systemic medication which could interfere with the trial objective within 2 weeks before randomisation until end of trial.
* Use of drugs which might cause photobiologic or phototoxic reactions within 4 weeks before randomisation until end of trial.
* Foreseeable intensive UV light exposure (solar or artificial) to test fields within 4 weeks before randomisation until end of trial.
Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study

The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are:

- what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease?

Participants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18years old
* Advanced chronic liver disease (defined as LSM ≥ 10kPa)
* Ability to provide informed consent

Exclusion Criteria:

* Transjugular intrahepatic portosystemic shunt
* previous liver transplantation
* Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts)
* Hematological malignancy
Environmental Health Effects on Your Physiology

This study evaluates the associations between exposure to air pollutants, green space, and the gut microbiome and metabolome.

A rapidly evolving field of study suggests a link between the gut microbiome and fecal metabolome with obesity. Recent studies show that environmental exposures, such as ambient air pollution (AAP) exposure can affect gut bacteria and modify risk for obesity. Additionally, proximity to green space has been shown to reduce exposure to air pollutants and increase gut microbial diversity. The investigator's preliminary work has shown that near-roadway air pollution exposure was positively correlated with gut microbial taxa that have been linked with obesity. These findings suggest that air pollution exposure may increase susceptibility to obesity through alterations in the composition and function of the gut microbiome. Despite this, no studies have systematically examined the impact of air pollutants and green space on the gut microbiome and metabolome among adolescents. The overall goal of this research is to determine whether exposure to air pollutants and/or green space affect the gut microbiome and metabolome in young adults residing in Denver, Colorado. This study will examine residential-based estimates of air pollution exposure and green space and also perform detailed gut microbial and metabolite profiling in 100 adolescent and young adults.

Eligibility Criteria:
Inclusion Criteria:

* The participant population includes young adults (18-25 years of age) who live in Denver, Colorado.

Exclusion Criteria:

* Exclusion criteria include physical, mental, or cognitive disability that prevents participation
* Current incarceration
* Antibiotic usage in the previous month
* Pregnant or nursing
* Non-English speaking
* Any medical conditions known to affect body composition, insulin secretion, or the gut microbiota (i.e., type 1 or 2 diabetes, intestinal bowel disease, Crohn's Disease, kidney disease, heart disease, autoimmune disease).
Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

PURPOSE: To evaluate the efﬁcacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).

METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.

A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.


Eligibility Criteria:
Inclusion Criteria:

* type 1 or type 2 diabetes mellitus patients
* older than 18 years
* with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).
* nonresponsive to bevacizumab, deﬁned as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF\>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).

Exclusion Criteria:

* additional ocular diseases that could significantly affect the visual acuity such as:
* significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema
* age-related macular degeneration
* retinal vascular occlusion
* central corneal opacity
* amblyopia
* advanced glaucoma
* optic neuropathy
* history of ocular trauma or surgery other than uncomplicated cataract extraction
* cataract surgery within 3 months before or after bevacizumab switch
* unable to provide written informed consent.
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients

Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.


Eligibility Criteria:
Inclusion Criteria:

* diastolic blood pressure \> 95 mmHg and \< 110 mmHg
* systolic blood pressure \> 140 mmHg and \< 180 mmHg
* no amlodipine therapy for the previous 6 months

Exclusion Criteria:

* diastolic blood pressure \> 110 mmHg and or
* systolic blood pressure \> 180 mmHg
* secondary hypertension
* heart failure
* diabetes mellitus
* liver or kidney diseases
Investigation of the Role of Human Papilloma Virus (HPV) in the Prognosis of Head and Neck Cancer

Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important questions remain however, regarding the role of specific types of HPV, their effect on prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with other risk factors (such as smoking and alcohol), and potential geographical differences in the effect of HPV.

Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which is an international collaboartive case-control study conducted in 15 centres in 11 European countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a systematic analysis of HPV subtypes known or suspected to be involved in head and neck cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx, hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by exposure to other known or suspected carcinogens including tobacco, alcohol and medical history.

It is intended that this work will contribute to the development of evidence that may feed into treatment protocols for these cancers as well as evaluations of the feasibility for extending HPV vaccine programs.


Eligibility Criteria:
Inclusion Criteria:

* Consent to follow-up and use of tissue samples

Exclusion Criteria:

* No existing consent
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP).

Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L).

Approximately 534 randomized subjects will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
* Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:

  1. FL Gr 1, Gr 2, or Gr 3a
  2. MZL (splenic, nodal, or extra-nodal)
* Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
* Subjects must have at least one bi-dimensionally measurable lesion \>1.5 cm
* Adequate hematologic parameters at screening unless abnormal values are due to disease
* Adequate renal and hepatic function
* Adequate cardiac function based on ECG and LVEF assessments

Exclusion Criteria:

* Histologically confirmed diagnosis of FL Gr 3b or transformed disease
* Prior therapy with PI3K inhibitors
* Ongoing or history of drug-induced pneumonitis
* Known lymphomatous involvement of the central nervous system
* Tested positive for or active viral infection with hepatitis B or C virus
* Tested positive or active infection with human immunodeficiency virus
* Tested positive, or active infection with human T-cell leukemia virus type 1
* Any uncontrolled clinically significant illness
* History of clinically significant cardiovascular abnormalities such as congestive heart failure
* History of clinically significant gastrointestinal (GI) conditions
* Females who are pregnant
Feasibility of a Minimally Invasive Thoracoscopic Ultrasound for Localization of Pulmonary Nodules

The ex-vivo lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images between deflated and inflated lung. After ultrasound evaluation, the specimen will be delivered directly to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using HE slides of lung tumor. We will work together with the surgical team to confirm sign off of specimens.

This is a single center clinical trial. Forty patients (sufficient for an initial evaluation) scheduled for a lobectomy or an anatomical segmental resection for malignant lung tumors will be enrolled in the study. After lung resection, the lung will be placed on a surgical table in a similar position to the in-vivo situation in the Image Guided Therapeutic operating room (GTx-OR) within Toronto General Hospital. The lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images between deflated and inflated lung. After ultrasound evaluation, the specimen will be delivered directory to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using Hemotoxylin and Eosin (HE) slides of lung tumor. We will work together with the surgical team to confirm sign off of specimens.

Eligibility Criteria:
Inclusion Criteria:

* Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
* 18 Years of age and older

Exclusion Criteria:

* Any patients with inability to give informed consent
VA Home-Based Emotional Learning With Practical Skills

The purpose of this study is to determine the feasibility and acceptability of providing evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression via telephone to rural Veterans receiving home-based primary care.

VA-HELPS will include flexibility in both content and delivery to meet the needs of Home Based Primary Care (HBPC) Veterans. Content will be modular to meet the needs of both anxious and depressed participants. Modular skills-based treatment has been used successfully with a range of clinical problems (Chorpita et al., 2004; Henin et al., 2001; Wetherell et al., 2009, 2011), including our own group's work treating generalized anxiety disorder (GAD) in primary care (Calleo et al., in press) and anxiety-depression in patients with chronic illness (Cully et al., 2010). To further support a patient-centered treatment approach, patients will have the opportunity to include R/S. Research points to the importance of R/S in coping with illness, with 50-90% of patients reporting using their belief systems to enhance coping skills (Koenig \& Adams, 2008). Along with content modifications, delivery of treatment should complement the needs of HBPC Veterans. Providing one initial in-home session, followed by telephone contact for subsequent sessions, allows cost effectiveness to be taken into consideration; and greater numbers of rural HBPC patients will have access to the intervention.

Treatment will involve approximately 6 to 8 weekly sessions lasting approximately 30-40 minutes each. After the first in-person session, all sessions will be delivered via telephone. At least one booster call (15-20 minutes) will occur during the month following completion of active treatment. All participants will complete assessments at baseline, 8 weeks, and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Part of Home-Based Primary Care
* Reside in a rural community, as defined by the US Census Bureau
* Symptoms of anxiety and/or depression

Exclusion Criteria:

* Significant cognitive impairment
* Active suicidal intent
* Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month