cyrilzakka/clinical-trials huggingface dataset:
MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

The purpose of the study is to combine and correlate data from morphological and functional MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia with the goal being predicting of prostate cancer aggressiveness.

A prospective study including 180 consecutive patients with PCa referred to Oslo University Hospital, Radiumhospitalet, for surgical treatment. In vivo functional MRI examination will be performed within a few days prior to robot-assisted radical prostatectomy (RALP). For a subgroup of patients FACBC PET will also be acquired prior to prostatectomy. A subgroup of intermediate and high-risk patients (D'Amico risk classification) will prior to surgery receive an intravenous infusion of the hypoxia-marker pimonidazole (Hypoxyprobe™-1)\*. During surgery, bone marrow aspiration and blood collection will be performed for assessment of disseminated and circulating tumor cells. High-risk patients will undergo intraoperative lymph node dissection. Tumor tissue for molecular analyses will be sampled from prostate specimen prior to fixation. Prostate specimen and regional lymph nodes will be histopathologically examined for T- and N-classification, Gleason grade, presence of micrometastasis and areas of hypoxia. Histological and molecular findings will be correlated to MRI and PET findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death).

\*From 2013 oral administration is used.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for surgery with confirmed prostate cancer, Gleason grade ≥ 3
* Patient has received no prior treatment for prostate cancer.
* Patient has adequate renal function: Estimated creatinine clearance ≥ 60 ml/minute.
* Patient must sign written informed consent according to the protocol approved by the Regional Ethics Committee.

Exclusion Criteria:

* Patient with contraindication to MR or MR contrast media according to clinical practice.
* Patients who want to withdraw for any reason during the study.
* Patients previously undergone pelvic surgery or radiation therapy
Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

Given the high rates and associated impairment of sexual concerns during the menopausal transition, and specifically during perimenopause, our team has developed a CBT protocol specifically designed to target these prevalent and distressing sexual concerns. The broad aim of the proposed study is to validate this new protocol in a clinic that provides empirically-supported assessment and intervention services for women with menopause-related symptoms. The primary objective of this study is to evaluate the efficacy of a four-week individual CBT protocol in improving sexual satisfaction and reducing distress during perimenopause. The secondary objective of this study is to evaluate the efficacy of this CBT protocol to improve sexual functioning (e.g., desire, arousal), relationship satisfaction, and body image. Exploratory analyses will examine the impact on this CBT protocol on vasomotor symptoms, depression, and anxiety.


Eligibility Criteria:
Inclusion Criteria:

1. 40-60 years of age;
2. peri-menopausal and have had a menstrual period within the previous twelve months as per the STRAW definition (Harlow et al., 2012);
3. cut-off score of 26 or lower on the Female Sexual Functioning Index, indicating sexual dysfunction (Wiegel et al., 2005);
4. medication stable (e.g., hormone therapy), with no changes in dosing for the previous three months (Green et al., 2019);
5. no psychological treatment to address sexual dysfunction and/or sexual concerns within the previous six months; and
6. speak, read, and write in English to comprehend testing procedures and written materials in treatment
7. living within Canada

Exclusion Criteria:

1. participants with psychotic disorders, or current substance and/or alcohol dependence; and
2. participants who are severely depressed/suicidal at time of the intake assessment.
A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
* Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
* Have adequate biliary drainage.
* Have adequate organ function.
* Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method.
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose.
* Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations.

Exclusion Criteria:

* Previous systemic therapy for locally advanced or metastatic disease is not allowed.
* Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade \>1, or cirrhosis with Child-Pugh Stage B or higher.
* Have ongoing or recent (≤6 months) hepatorenal syndrome.
* Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization.
* Anticipate having a major surgical procedure during the course of the study.
* Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
* Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
* Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management.
* Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
* Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
* Have a known allergy or hypersensitivity reaction to any of the treatment components.
* Have a history of uncontrolled hereditary or acquired thrombotic disorder.
* Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain.
* Have mixed hepatocellular biliary tract cancer histology.
* Have a corrected QT interval \>470 milliseconds as calculated by the Fridericia equation.
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
* Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.

Exclusion Criteria:

* Current use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than 2 biologic DMARDs
* Current use of more than one cDMARDs
* Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Optimizing Rural Community Health Through Dementia Detection and Care

The overall goal of this one-year study is to test a comprehensive protocol for Alzheimer's Disease and Related Dementias (ADRD) diagnosis and care management that can be used as a model for rural communities, which experience low rates of dementia diagnosis and treatment.

The ORCHID study integrates 1) A one-group community educational intervention focused on increasing community awareness of brain-health promoting behaviors and dementia literacy and knowledge; and 2) A primary care provider dementia educational intervention designed to improve provider knowledge and confidence in detecting, diagnosing, and treating patients with cognitive impairment, with the goal of increasing ADRD diagnosis and treatment rates, reducing dementia-related hospitalization rates, increasing utilization of available local support services, and improving caregiver-related outcomes.

The community education intervention is a 6-week culturally-relevant educational program focused on brain health promotion. Effects of the community intervention on dementia knowledge and literacy will be assessed with a pre-post analytic approach using paired t-tests to compare changes in mean AD knowledge and literacy. The provider dementia educational intervention uses a cluster-randomized trial design with participating primary care provider offices randomly assigned to either receive the intervention (Arm A) or the control group (Arm B). Providers assigned to Arm A receive an educational intervention that includes training in ADRD detection, diagnosis, and care management. Providers assigned to Arm B do not receive educational intervention. Both groups receive the following: detailed reports from neuropsychological testing performed by a study clinician, hands-on training of provider office staff on dementia screening tools, and support with referrals to local support services. The two study groups (Arms A and B) will be compared on: 1) change in provider dementia knowledge and confidence, caregiver burden and self-efficacy; and 2) rates of dementia diagnosis and treatment, rates of dementia-related hospital admissions, and rates of referral to support service. A generalized linear mixed model analytic approach will be used to assess the effect of the provider intervention on study outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years and older
* Lives in the Glades Area of Florida
* Lives in the community/ be non-institutionalized
* Has no known diagnosis of Alzheimer's Disease and Related Dementias
* Speaks either English, Spanish, or Creole
* Has no known plans to move out of the Glades Area in the next 12 months

Exclusion Criteria:

* Previous diagnosis of a dementia-related illness
* Aged under 50 years
Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (89Zr-DFO-CZP) PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging.

This is a single center exploratory imaging study investigating the initial application of 89Zr-DFO-CZP PET in patients with rheumatoid arthritis. Patients with active symptoms of rheumatoid arthritis (RA) or signs on physical exam will be invited to participate for PET imaging. Study 1 is a dose finding study that will involve a single 89Zr-DFO-CZP PET scan acquired \~24 hours following a single administration of the radiopharmaceutical. The first 2 patients will receive 1 millicurie (mCi) of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. After receiving the dose, participants will undergo 4 serial whole body PET scans between 2 hours and 120 hours after dose administration. Several blood samples will also be collected over this time period, for dosimetry analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old.
2. Ability to read and understand written informed consent document.
3. Patients with clinical diagnosis of rheumatoid arthritis.

Exclusion Criteria:

1. For patients planning to be imaged on PET (positron emission tomography) / MRI (magnetic resonance imaging) (PET/MR) scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia.
2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator.
3. Patients who have had a study involving radiation within one year of enrolling in this study.
4. Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study).
5. Patients who are breastfeeding.
6. Patients who cannot confirm that they will use reliable contraceptive methods for 90 days.
7. Patients treated with TNF-alpha inhibitor therapy.
8. Females of child-bearing age (\<50 years old), until data from the dose-finding study has been reviewed by the UCSF Radiation Safety Committee and explicit written permission has been provided by the UCSF Radiation Safety Committee to open the window of potential female participants to ages 18 years and older.
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis

This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:

  1. Tibiotalar (ankle)
  2. Talocalcaneal (subtalar)
  3. Talonavicular
  4. Calcaneocuboid
  5. Double hindfoot (e.g., talonavicular and talocalcaneal joints)
  6. Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
* Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
* Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
* Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
* If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up

Exclusion Criteria:

* Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
* Bone deficit, defect or void requiring a structural graft
* Condition requiring intramedullary nailing or external fixation for the arthrodesis
* Condition requiring osteotomy or fusion of any midfoot joints.
* Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.
Posterior Nasal Nerve Neurectomy for Treatment of Intractable Allergic Rhinitis

This study aims to compare the outcomes of posterior nasal nerve neurectomy in patients with resistant Allergic rhinitis by using three different methods ( surgical resection vs radiofrequency ablation vs surface coblation ) through assesment of functional outcomes, postoperative complications, and impacts on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 to 65 years, fit for surgery, diagnosed as moderate to severe persistent Allergic Rhinitis, as per the ARIA guidelines having 3 or more of the typical symptoms of Allergic Rhinitis including nasal discharge, repeated attacks of sneezing, nasal itching and nasal obstruction.

Exclusion Criteria:

* • Patients with Coexisting nasal pathologies that could influence the outcomes of the surgery like: chronic granulomatous diseases of the nose, nasal tumors, chronic sinsitis with or without nasal polyps, etc.

  * Patients who had used topical steroid nasal spray, oral or topical antihistamines, oral leukotriene antagonists, oral or tobical nasal decongestants in the last 2 weeks.
  * Immunocompromised patients, Systemic disease affecting prognosis such as diabetes mellitus, hypertension,chronic liver failure or heart failure.
  * Unwillingness for endoscopic surgery.
  * Patients younger than 18 years of age.
  * Patients who are unfit for general anesthesia.
  * Previous history of nasal surgery
Immunotherapy in Lung Cancer: Treatment After IO Cessation.

Immunotherapy is now a standard of care for first-line and eventually salvage therapy in patients with stage IV NSCLC and as adjuvant after RT-CT for stage III NSCLC.

The aim of the study is determining the therapeutic landscape and the reason for immunotherapy cessation.

Patients with stage IV or unresectable not irradiable stage III NSCLC will be registered at the time receiving immunotherapy alone or in combination with chemotherapy.

When IO is stopped, reason for cessation and further treatment will be recorded.

Secondary endpoints are survival after IO cessation, activity of first salvage therapy, disease-free survival after IO cessation in patients receiving no further treatment.

Patients will be centrally registered at the ELCWP headquarter (Institut Jules Bordet, Brussels, Belgium).

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of non-small cell lung cancer (NSCLC)
* Stage IVA/IVB and unresectable and non irradiable stage III NSCLC naïve of immunotherapy.
* Patients who receive immunotherapy (any type) monotherapy, combined immunotherapy or in combination with chemotherapy for first or second-line treatment.
* Availability for participating in the detailed follow-up of the protocol.
* Signed informed consent.

Exclusion Criteria:

* Patients receiving adjuvant immunotherapy for stage I-III NSCLC are not eligible
* Tumours for which TNM stage at time of study inclusion cannot be assessed.
* History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumor (more than 5-year disease free interval).
* Any type of immunotherapy for previous cancer
Impact of Glycine Therapy on Peri-implant Mucositis

The purpose of this research study is to determine the impact of glycine powder air-abrasive debridement (GPAD) on the microbiology of the tissues surrounding dental implants with health and inflammation (peri-implant mucositis).

Peri-implant mucositis, or the infection of the gingival tissues surrounding a dental implant, and peri-implantitis, or the infection of the gingival tissue surrounding a dental implant with bone loss, can lead to the failure and eventual loss of dental implants. The prevalence of peri-implant mucositis ranges from 30.7-43% and the prevalence of peri-implantitis ranges from 9.6-22% with non-smokers. Traditional treatment of this disease has been through biofilm removal using ultrasonic instrumentation. Glycine is a non-essential amino acid that possesses an anti-inflammatory, immunomodulary, and a cytoprotective effect. The goal of this investigation is to examine the impact of glycine-augmented biofilm removal on resolution of peri-implant mucositis

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Must have \>1 tooth-borne, non-splinted single dental implant
* Signs of healthy dental implants (pocket probing depth \<4mm and a lack of bleeding upon probing at peri-implant site) OR
* Signs of peri-implant mucositis (\> 4mm probing pocket depths at the dental implant site, bleeding upon probing at \>1 peri-implant site, pre-brushing plaque score of \> 1.9 (modified Plaque Index (mPI)), and radiographic evidence of bone loss less than 2mm).

Exclusion Criteria:

* Uncontrolled medical condition (i.e. Diabetes, History of smoking \<5 years)
* Pregnant or lactating females
* Untreated periodontal conditions
* Use of antibiotics in the past 3 months
* Subjects treated with medication for \>2 weeks with known effects to the oral tissues (i.e. coumadin, phenytoin, nifedipine, cyclosporine, non-steroidal anti-inflammatory drugs)
* Signs of peri-implantitis (pocket probing depth of 4-6mm with bleeding upon probing at \>1 peri-implant site AND radiographic bone loss)
* Dental implant mobility