cyrilzakka/clinical-trials huggingface dataset:
Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring

Men with localized prostate cancer (PCa) with small tumor burden may be followed on active surveillance (AS) rather than active treatment. AS is an attempt to avoid over-treatment of PCa, which is estimated to be insignificant at the time of diagnosis, and therefore unlikely to affect patient morbidity and mortality. AS include close monitoring with PSA measurement (blood test), digital rectal exploration (DRE) and trans-rectal ultrasound-guided prostate biopsy (TRUS-bx) at regular intervals, so that active treatment can be initiated if the cancer becomes more aggressive. It is crucial that patients undergoing AS are staged correctly, to avoid underestimating more aggressive disease and patients mistakenly are enrolled into AS instead of active treatment.

Previously, a PhD study conducted at Herlev Hospital revealed that multiparametric MRI (mp-MRI) of the prostate can improve the detection and staging of PCa and may add additional information about tumor aggressiveness compared to the traditional methods DRE and TRUS-bx. Mp-MRI at the inclusion of AS may detect missed significant tumors and potential areas of higher aggressiveness than detected by the traditional biopsies. Additional targeted biopsies from these suspicious areas can then be performed with a re-evaluation of the treatment plan, if more advanced disease is identified. Conversely, mp-MRI has a high negative predicted value for significant disease and can be used to rule out significant PCa, reassuring patients and physicians to go on with AS. Mp-MRI has been used at the Urology Department, Herlev Hospital, since 2013 in the diagnosis of PCa and in the evaluation of patients undergoing AS. A retrospective study have show that mp-MRi improve the detection of missed significant PCa.

The main objective of this study is now to prospectively investigate, whether mp-MRI can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patients with low risk localized prostate cancer enrolled in active surveillance

Exclusion Criteria:

* Metastatic prostate cancer
* No mp-MRI data present
* Prostate cancer treatment
* Known allergic reaction to Gadolinium-based MRI contrast agent
* Prostate biopsy during the last 21 days
* Impaired renal function with GFR \< 30 ml / min
* pacemaker
* Magnetic metal residues in the body
* Claustrophobia
* Psychiatric disorders
* Age under 18 year
Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment

This study evaluates the addition of an educational intervention program in order to improve medication adherence in glaucoma patients. Half of the participants will receive the educational program while the other half will receive normal care and a leaflet about glaucoma.

Introduction. As the world population ages, glaucoma is becoming an increasingly significant cause of blindness. Statistics gathered by WHO in 2010, show that glaucoma is the leading cause of irreversible blindness, worldwide. A key component in the management of glaucoma, is the use of prescribed medications· but the effectiveness of medications depends on patient's adherence to treatment. However, there is evidence of poor adherence to prescribed medication in chronic diseases and a causative factor for that is the limited education and the low health literacy. This study aims to investigate the reasons of non-adherence to the medication plan among patients with glaucoma and secondly, according the findings, to develop and implement a comprehensive educational program.

Methods and analysis. This is a mixed method study which include 3 stages: a descriptive study (stage 1), focus group discussion (stage 2) and a randomised control trial (stage 3). Sample: Patients with glaucoma, using at least one kind of drops, will be recruited from the two ophthalmology clinics in Cyprus. Selected measures include: Glaucoma Treatment Compliance Assessment Tool (GTCAT), European Health Literacy Survey Questionnaire (HLS-EU-Q6) and the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ). The data will be analysed by SPSS program with descriptive and inferential statistics. Content analysis will be used for the data from the focus groups.

Ethics and dissemination. Permission to conduct the study received from the Cyprus National Bioethics Committee (ΕΕΒΚ ΕΠ 2019.01.220) and the board of management of the two ophthalmology clinics. All participants will be informed fully on the purpose and methods of the study. Consent forms will be signed and at any time participants will have the right to withdraw. Confidentiality of the participants will be respected as also the protection of data. Dissemination strategy includes presentations in international and national scientific conferences and publications in scientific journals.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Ability to read and understand Greek
* Able to give informed consent
* Diagnosis of glaucoma or ocular hypertension, requiring treatment with hypotensive eye drops (at least one time per day).
* Patients who scored less than 80% adherent on GTCAT

Exclusion Criteria:

* None
Continuous Glucose Monitorization in Hospitalized Patients With COVID-19

DM2 is a major comorbidity of COVID-19. It has been observed that subjects with DM2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics.

In situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase C can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .Patients with diabetes and COVID-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 pneumonia
* Diabetes mellitus

Exclusion Criteria:

* Less than 3 days of hospital care
Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with non-relaxing puborectalis syndrome. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS. All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals.

Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses to these treatments have been variable at best. Direct injection of botulinum toxin (Botox) into the puborectalis muscle is an alternative approach for treating NRPS and has recently been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the autonomic nervous system and has been used to weaken the puborectalis muscle in constipated patients.

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with NRPS. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS.

We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox injection into the puborectalis muscle in patients with NRPS.

All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional injections will be offered to patients who fail the initial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Diagnosis of non-relaxing puborectalis syndrome

Exclusion Criteria:

* Allergy or sensitivity to botulinum toxin
* Pregnancy or plan to become pregnant in the subsequent 6 months after injection
* Undiagnosed ano-rectal mass, lesion, or infection
* Stage II or greater rectocele
A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration Catheter

This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.

The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Baseline NIHSS score ≥6;
* Subject has acute occlusion located in Vertebral artery(VA) / Internal Carotid Artery (ICA) / M1or M2 segment of Middle Cerebral Artery (MCA) / Basilar artery (BA) diagnosed by DSA;
* Femoral artery puncture is expected to be completed within 24 hours of onset；
* mRS score≤ 2;
* Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.

Exclusion Criteria:

* Chronic occlusion in the target area;
* Epilepsy at the time of stroke；
* Bleeding from the gastrointestinal or urinary system in the past three weeks；
* After drug control, systolic blood pressure was greater than 185mmhg and / or diastolic blood pressure was greater than 110mmhg;
* International Normalized Ratio(INR)\>3;
* Random blood glucose \< 2.7mmol/L or \> 22.2mmol/L;
* Heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, - systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness);
* Tortuous lesion / severe stenosis in the starting segment of the carotid artery / Carotid dissection / Arteritis judged by researchers that is not suitable for the procedure;
* Acute occlusion of bilateral carotid arteries；
* Intracranial hemorrhage or massive infarction diagnosed by CT or MR;
* History of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents;
* Expected life \<12 months;
* Female subjects who are pregnant or planning to become pregnant or lactate within the study period;
* Subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent;
* Other circumstances judged by researchers that are not suitable for enrollment .
Thresholds In Food Allergy evaluaTion And predictioN

Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors.


Eligibility Criteria:
Inclusion Criteria:

1. Suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific IgE. A suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food.
2. Ability to discontinue all antihistamines for 1 week before oral food challenge.

Exclusion Criteria:

1. Previous desensitization treatment to a food allergen
2. Allergies to any component of the oral challenge vehicle
3. Unstable conditions including uncontrolled asthma or chronic urticaria
4. Any clinically significant disease/chronic medical condition which may interfere with study evaluations.
Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin

This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators wish to investigate. The primary objective is to measure peel force on normal skin and peel force on peristomal skin, with the intent of determining if differences occur. The study hypotheses is that no differences exist.

This is a single center, non-invasive exploratory study utilizing a sample of convenience. This study compares three commercially available barrier materials on peristomal skin and normal abdominal skin.

Eligibility Criteria:
Inclusion Criteria:

* Colostomy, Ileostomy, or Urostomy patients at least 6 months post-surgery
* Males or females, age 18 to 80 years old at the time of enrollment
* Body Mass Index (BMI) between 18 and 50
* Willing to have two approximately 5" x 5" areas of the abdomen trimmed with a surgical clipper -- one in a ring around the stoma, and one on the opposite side
* Willing to remain within the testing room for the duration of the study
* Willing to allow a third person in the room as a witness for the duration of the study
* Able to position oneself onto and off of the examining table without the assistance of the Investigator
* Willing to refrain from vigorous exercise for the duration of the study
* Willing to not take any anti-inflammatory medications (except for Tylenol/acetaminophen) starting 48 hours prior to the study and for the duration of the study
* Willing to bring an extra barrier and replace their barrier worn during the study.
* Willing to follow the protocol as demonstrated by signing the Informed Consent Form
* In the opinion of the Investigator or qualified site personnel is qualified to participate

Exclusion Criteria:

* Clinically significant diseases, which may or may not be confined to the testing site, that may contraindicate participation; including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
* Use of topical drugs on the application site within 1 month.
* Use of lotions, creams, powders or oils on the application site in the 24 hours prior to application
* Pregnancy, lactation or planning a pregnancy as determined by interview only
* Other medical conditions, for example uncontrolled diabetes, which in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk
* Participation in any clinical test either using the abdomen as a test site or using systemic therapy within the previous thirty days
* Damaged skin or other skin conditions in or near test sites which includes sunburn, scars, numerous moles or other disfiguration of the test site
* Significant adipose tissue at the test site that would preclude adequate adhesion of the study devices
* Known allergy to any of the test materials
The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels

Chemotherapy is a treatment that uses natural or synthetic chemicals and biological agents to kill rapidly proliferating cells. As chemotherapeutic drugs prevent the growth and proliferation of cancer cells, they also inhibit the growth of normal cells such as intestinal and oral mucosal epithelium, bone marrow cells, and hair follicle cells. During chemotherapy treatment, which is widely used in the treatment of cancer cases and considered one of the most effective methods of cancer treatment, individuals; may experience side effects such as nausea-vomiting, loss of appetite, mouth ulcers, pain, fatigue, anxiety, depression, sleep problems, and changes in their skin and nails.

There are several factors that can trigger anxiety in cancer patients: fear of cancer and its treatment-related side effects, fear of relapse after treatment, uncertainty, concerns about changing roles and relationships, and fear of death. Treatment methods are available for a variety of side effects and negative effects experienced by cancer patients. These methods include pharmacological and nonpharmacological approaches. For example, benzodiazepines are frequently used to treat anxiety in cancer patients. If benzodiazepines are not adequate, low-dose antipsychotics can be used. However, benzodiazepines and their derivatives may reduce respiratory function, induce sedation, and cause confusion.

Music is an example of non-pharmacological cognitive-behavioral treatment that is used to control negative symptoms in many fields. The use of music for healing is easy, has no side effects, and is beneficial for physical, psychological, emotional, and spiritual well-being. Anxiety and fear can be reduced by therapeutic music, which increases endorphin secretion and positive emotions. Treatment of serious illnesses such as cancer requires a holistic approach that includes psychological, social, and spiritual support in addition to pharmacological treatment. Therefore, the purpose of this study is to examine how different types of music affect cancer patients' anxiety and satisfaction during chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old,
* Receiving chemotherapy for the first time.

Exclusion Criteria:

* Hearing or vision problems,
* Have a lower education level than secondary school (The STAI is appropriate for those who have at least a sixth-grade reading level),
* Diagnosed with psychiatric and neurological diseases,
* Diagnosed with dementia,
* Received chemotherapy treatment more than once,
* Planned to receive radiotherapy treatment together with chemotherapy.
Muscle Relaxation Therapy With Odorant Cue

A novel procedure for generalized anxiety disorder where an odorant cue is paired with the state of deep relaxation during training. It is hypothesized that by smelling the odor in an anxiety-provoking situation, the patient will more easily invoke a state of relaxation, providing greater relief from the distressing tension and worry that characterize GAD.

We hypothesize that by presenting a novel odor to a patient in a state of deep relaxation, the odor will serve as a conditioned inhibitory stimulus, or safety signal, in anxiety-provoking situations. With the odor serving as a contextual cue for the state of relaxation.

Eligibility Criteria:
Inclusion Criteria:

* GAD without a comorbid active major psychiatric disorder.
* GAD must be the primary active psychiatric disorder.
* GAD determined via the Mini International Neuropsychiatric Interview (MINI).

Exclusion Criteria:

* Significant medical illness that might interfere with the relaxation therapy or with training using the odorant.
* Actively abusing alcohol.
* Illicit substances.
* Currently using rapid-acting anxiolytic agents (e.g. benzodiazepines, hydroxyzine).
* Started an antidepressant, antipsychotic or mood stabilizing agent within three months of screening visit.
Nerve Transfer for Finger Sensory Reconstruction With Dorsal Branch of the Digital Nerve

A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger pulp, which results in functional disability.The dorsal branch of the PDN can be transferred for reconstruction of such nerve defects.In this study, the investigators modified the Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN defects. For comparison, the investigators collected a consecutive series of 32 patients with finger PDN defects treated using a traditional sural nerve graft from February 2005 to October 2008.


Eligibility Criteria:
Inclusion Criteria:

1. Finger PDN defects proximal to the proximal interphalangeal joint
2. Single or two PDN defects
3. PDN defects longer than 1 cm.

Exclusion Criteria:

1. PDN defects less than 1 cm
2. Concomitant injuries to the multiple dorsal sensory branches that preclude their use as nerve donor sites
3. Thumb PDN defects.
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.


Eligibility Criteria:
Inclusion Criteria:

* Previous treatment in studies of pegloticase i.v.
* Last exposure to pegloticase i.v. greater than one year prior to study entry
* Symptomatic gout
* Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria:

* Prior exposure to Elitek® (rasburicase)
* Unstable angina
* Uncontrolled arrhythmia or hypertension
* Non-compensated congestive heart failure
* End stage renal disease requiring dialysis
* Concomitant use of SUA lowering agents and use of other investigational drugs
Implementing Genomics in Practice (IGNITE): CYP2D6 Genotype-Guided Pain Management in Patients Undergoing Arthroplasty Surgery

This will be a randomized, open-labeled pilot pragmatic clinical trial. Patients undergoing arthroplasty surgery will be recruited from the University of Florida (UF) Health Gainesville and the Villages Orthopedic clinics for CYP2D6 pharmacogenetic testing to manage post-surgical pain. Patients will be randomized 2:1 to either usual care or genotype-guided care. The aims of the study were to: 1) test the feasibility of a genotype-guided opioid prescribing approach for patients undergoing an outpatient surgical procedure, a group at high risk for persistent opioid use; and 2) evaluate the effect of genotype-guided post-surgical pain management on pain control and opioid prescribing.

This study was a randomized, open-label, type 2 hybrid implementation effectiveness trial conducted to test the hypothesis that CYP2D6 genotype-guided management of post-surgical pain 1) was feasible, and 2) reduced the use of codeine, tramadol, hydrocodone, and oxycodone in Poor Metabolizers (PMs), Intermediate Metabolizers (IMs), and Ultrarapid metabolizers (UMs). In addition to the reduced use of opioids listed above, we aimed to see if participants had improved post-operative pain control in PMs/IMs and reduced Drug Enforcement Administration (DEA) Schedule II (C-II) opioids in Normal Metabolizers (NMs). Patients scheduled to undergo arthroplasty surgery were recruited from the UF Health Gainesville and the Villages Orthopedic clinics. Patients were randomized 2:1 to a genotype-guided versus usual care approach. For patients with CYP2D6 PM, IM or UM phenotype based on genotype or drug interactions, a recommendation to avoid hydrocodone, tramadol, codeine, and oxycodone were made. In NMs, tramadol was recommended, given evidence of its lower potential addiction risk than C-II opioids. Patient-Reported Outcomes Measurement Information System (PROMIS) measures were administered at baseline (within 30 days of surgery) and 2 weeks ± 4 days post-surgery for patients in each arm. Pain scores and assessments of physical functioning, emotional functioning, and mobility from the PROMIS measures and utilization of pain medications during the 2-week period following surgery were also compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo total joint arthroplasty at area hospital
* Primary unilateral total hip or knee arthroplasty scheduled within approximately 6 months of the initial evaluation clinic visit

Exclusion Criteria:

* Patients scheduled to undergo a revision or bilateral procedure
* Receiving chronic opioid therapy, defined as the use of opioids on most days for \> 3 month
* Allergy to opioids