cyrilzakka/clinical-trials huggingface dataset:
A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease

The purpose of this Delphi study is to identify priority outcomes for self-management in earlier (non-dialysis) stages of CKD from the perspectives of different stakeholder groups in the UK. The findings of this study will be used to inform outcome measure selection for research and clinical evaluations of self-management resources and to support implementation, commissioning and uptake.

Chronic Kidney Disease (CKD) is a progressive condition affecting more than 1.8 million people in England

Effective self-management is important for people living with CKD like many Long-Term Conditions. Self-management in its broadest term can be summarised as individuals participating in the day-to-day management of their chronic condition

Theory- and evidence-based tools and resources for self-management education and support are required to encourage health-promoting behaviours. However, outcomes valued by key stakeholders are necessary to ensure robust evaluation in research settings and clinical practice

A Delphi study is carried out to generate consensus on outcomes that are valued by the stakeholder groups in this study. The Delphi study will undergo 3-4 survey rounds

Adult CKD patient participants living in the UK and their significant others were recruited via social media adverts shared by our research team and English kidney community organisations. Healthcare professionals, commissioners and policymakers (professional groups) based in the UK were recruited by direct email invitations to our extensive contacts in the field

Eligibility Criteria:
Inclusion Criteria:

* People with diagnosis of CKD in the UK
* Their close family and friend
* Healthcare professionals who look after people with CKD in the UK
* Anyone involved in designing, developing, managing and commissioning CKD healthcare services in the UK
* Researchers related in a topic related to self-management or CKD

Exclusion Criteria:

* Any participant residing outside of the UK
Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic Carcinoma

The aim of this study is to explore the effect of SAMe on recurrence after radical treatment of Primary liver cancer.

Primary liver cancer is now a major health problem. In the worldwide, PLC is the fifth most common cancer in male, the seventh in female, and has the second highest rate to cause death for men . Although the recent advances in treatment of Primary liver cancer have significantly improved the prognosis of patients with Primary liver cancer, the overall survival rate is still unsatisfactory. One of the reasons for the poor prognosis of Primary liver cancer is its high rate of recurrence. Anti-relapse treatment remains a pressing work to do.

In recent years, some study reported that SAMe had an impact on promoting apoptosis and inhibiting the growth on breast cancer, colon cancer, gastric cancer and liver cancer in vitro and vivo.

In this study, we aim to examine whether SAMe have an effect on improving patients' recurrence after radical treatment of Primary liver cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient must sign the informed consent prior to the beginning of any study-related procedures;
* Patients diagnosed of Primary liver cancer;
* BCLC Stage：Stage 0、Stage A;
* Accept radical treatment;

Exclusion Criteria:

* With any other anti-cancer treatment before or after the surgery;
* Patients with extrahepatic metastasis;
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction;
* Subjects accepting other trial drugs or participating in other clinical trials;
* Female with pregnancy or during the lactation period.
Vestibular Testing: Consistency and Effects Over Time

The goal of this study is to test the consistency and repeatability of a portable goggle system for testing optokinetic, ocular, and reaction time. The study examines the day to day consistency, time of day and learning effects as well as any secondary motion sickness.

The goal of this study was to test the constancy and repeatability of this test by testing it in different individuals and different times of day, after a variety of tasks and after repeated performance

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Both Females and males
* Staff and students at all levels at the University of Miami or first-degree - relatives/significant others of those individuals.

Exclusion Criteria:

* History of vestibular disorder/dysfunction
* Central processing disorder
* Impaired vision without corrective lenses (max 20/60 uncorrected)
* Moderate to severe hearing loss \[\>55 decibel (dB) Pure Tone Average (PTA), \<50% word identification\]
Synovectomy in Primary Total Knee Arthrplasty

The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.


Eligibility Criteria:
Inclusion Criteria:

* patients with primary osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

* Inflammatory arthritis
* Revision knee arthroplasty
Case Collection Study to Support Digital Mammography Image Software Change

The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.


Eligibility Criteria:
Inclusion Criteria:

* Female
* \> 40 years

Exclusion Criteria:

* Pregnant women, or women who may become pregnant
* Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
* Palpable lesion or one that is visible by another modality
* Inmates
Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.

Biliary anastomotic stricture is a common complication of after end-to-end biliary anastomosis. Magnetic recanalization is a promising way to establish connection of biliary tract after stenosis or completed obstruction. This study is designed to investigate the safety and efficacy of magnetic recanalization among patients with severe biliary stricture after biliary anastmosis. Patients who failed to undergo stent placement with endoscopic retrograde cholangiopancretography (ERCP) would be enrolled for magnetic recanalization treatment. Magnetic treatment will be implemented by several steps. Firstly, placement of one magnet through the sinus of percutaneous transhepatic cholangio drainage (PTCD) in upper part of the bile duct; Second, introduction of another magnet via ERCP into the distal part of the bile duct, and making them be mated together; Third, after necrosis of the tissue between the two magnets, the magnets will drop off and be taken out together through the thread connected with them out of the mouth. Last, a plastic stent should be placed in the bile duct for a lasting support. The time of recanalization (drop off of the magnets), and adverse events (e.g. fever, melena, nausea, vomiting, anorexia, hematemesis, abdominal pain, and gastrointestinal bleeding) will be recorded, and each patient will be followed up for long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old and ≤65 years old
* 2. patients with biliary stricture after end-to-end biliary anastomosis

Exclusion Criteria:

* 1. Pregnant woman
* 2.Have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal Q wave (ECG)), stroke (ischemic or hemorrhagic, including transient ischemic attack)
* 3. Severe lung diseases such as COPD and asthma
* 4. Patients with acute infection or inflammation (i.e. pneumonia)
* 5. Any other medical condition considers the longest survival time to be less than 2 years
* 7. Immunodeficiency or HIV positive
* 8. No autonomy, inability to participate in follow-up
* 9. Illiterate
A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer

This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.

This is a prospective multi-centre trial in 5 hospitals in 3 countries to investigate the efficacy and complications of targeted Microwave Ablation as a minimally invasive focal therapy for prostate cancer. Men aged 50-75 with PSA \< 20ng/mL and clinically significant prostate cancer with 1-2 MRI lesions ≤15mm and ISUP grade group ≤3 will be recruited. Transperineal targeted Microwave Ablation of the prostate tumor(s) will be done with repeated ablations by a single microwave needle guided by MRI-Ultrasound fusion and organ-based tracking navigation. The primary outcome is any clinically significant prostate cancer detected on biopsy of treated area(s) per patient at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Men aged between 45 - 75 years
2. Life expectancy \> 10 years upon recruitment
3. Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial
4. Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
5. Organ-confined prostate cancer on MRI
6. PSA \< 20 ng/mL
7. 1-2 MRI visible lesion present and size ≤15mm, with targeted biopsy showing:

   * ISUP grade group 2 or 3, or
   * ISUP grade group 1 with tumor size ≥10mm

Exclusion Criteria:

1. Patients not fit for general or spinal anaesthesia
2. Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
3. Patients with coagulopathy that cannot be corrected
4. Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment)
5. Patients with previous treatment of prostate cancer
6. Patients with prior pelvic radiotherapy for prostate cancer or other cancer
7. Patients with maximal length of target lesion \>15mm
8. Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
9. . Patients with \>2 areas (MRI-visible or invisible) of prostate cancer
10. Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
11. Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable)
12. Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
13. Patients with bladder pathology including bladder stone and bladder cancer
14. Patients with known urethral stricture
15. Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery

Primary aim of this prospective, randomized, double-blind clinical trial is to compare the analgesic effects of intravenous paracetamol and ibuprofen on postoperative pain, and secondary aim is the effects on tramadol consumption and side effects of tramadol in patients who underwent unilateral shoulder surgery.

All surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. Effective postoperative pain management in shoulder surgery may reduce complications and improve postoperative care.

For postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms. Various analgesics are used for pain. Opioids, commonly used for postoperative pain, are the most popular drug group. Side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.

Adjuvant agents, including nonsteroidal anti-inflammatory drugs, may be used in combination with opioids. These drugs not only reduce pain but also control the underlying inflammatory process. In addition, combining nonsteroidal anti-inflammatory drugs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption.

Intravenous paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that intravenous paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. It provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids.

Intravenous ibuprofen is the first and only intravenous nonsteroidal anti-inflammatory drugs approved in the United States for both pain and fever control in adults. It has been reported in multicenter studies that IV ibuprofen is safe and effective in postoperative pain management for orthopedic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists scores 1-3
* 18-85 years

Exclusion Criteria:

* American Society of Anesthesiologists scores IV,
* Under the age of 18,
* Over the age of 85,
* Peptic ulcer disease,
* Hepatic and renal dysfunction,
* Severe cardiovascular and pulmonary disease,
* Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,
* Emergency surgery
eXciteOSA for Treatment of Mild Obstructive Sleep Apnea

The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus no-therapy for six weeks. Up to 200 participants will be enrolled, in order to randomized n=102.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>=18 years;
* Diagnosed with mild OSA;
* Smartphone or tablet capable of running the eXciteOSA app;
* Fluent in written and spoken English (all sites) or Spanish (one site only).

Exclusion Criteria:

* BMI \>=35 kg/m2;
* Implanted medical device;
* Dental braces and/or intraoral metal jewelry;
* Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;
* Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;
* Tonsillar hypertrophy (tonsil size grade 3 or greater);
* Clinically significant facial or oropharyngeal abnormalities such as class 2 malocclusion;
* Prior oropharyngeal surgery for sleep-disordered breathing;
* At-home use of a mandibular advancement device or PAP for sleep-disordered breathing within the previous four weeks;
* Use of any overnight therapy that cannot be withdrawn during study enrollment;
* Diagnosed with any sleep disorder other than OSA;
* Chronic use of central nervous system depressants;
* Driver in a sleepiness-related vehicular accident or near-miss within the two years prior to enrolment (self-report);
* Employed as a commercial driver, pilot, or other occupation that may be impacted by hypersomnolence;
* Considered by the PI to be at risk of an AE resulting from hypersomnolence;
* Any periods of non-connectivity (wifi or cellular data) exceeding 48 hours planned to take place, or likely to take place, during enrollment;
* Current or planned pregnancy;
* Member of a vulnerable population, including but not limited to prisoners and those lacking consent capacity;
* Clinically-significant burden of comorbidities, and/or any other limitation or condition that may impact the patient's ability to complete the study protocol and use the device per the Instructions for Use (PI discretion);
* Employee and/or residing household member who is an employee of a company that produces or distributes products designed to diagnose, treat, and/or monitor sleep or sleep-disordered breathing (including the Sponsor).
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:


Eligibility Criteria:
Inclusion Criteria:

* Informed consent of parent(s) or legal guardian.
* Males or females, 2 to 5 years old (inclusive).
* Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks.
* Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles).
* An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline.
* Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands).
* In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs and hematology values.
* Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator.

Exclusion Criteria:

* Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
* Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris
* Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
* Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
* Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period.
* Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period.
* Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
* Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol.
* Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.
Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1

The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C.

The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition (SC).

We expect that, relative to the SC condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV.

Eligibility Criteria:
Inclusion Criteria:

* Currently undergoing HCV treatment at RIH
* Enrolled in MMT for at least 6 months

Exclusion Criteria:

* Current major depressive episode
* Current suicidality
* Currently taking antidepressant medication
* Received HCV treatment in past
A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors

This study consists of dose escalation evaluation to determine the safety and tolerability of ADA-011 as a monotherapy. Following dose escalation, one or more dose expansion cohorts in selected indications will be explored to further evaluate the safety, tolerability, and preliminary efficacy of ADA-011.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (nonresectable) or recurrent and progressing since the last antitumor therapy and for which no recognized standard therapy exists
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Measurable disease per RECIST v1.1 or per other criteria best suited for the specific tumor type being evaluated
* Adequate organ function

Exclusion Criteria:

* Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 2 weeks prior to the first dose of ADA-011
* Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to the first dose of ADA-011
* Major trauma or major surgery within 4 weeks prior to the first dose of ADA-011
* AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia
* Known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection
* Active SARS-CoV-2 infection, irrespective of symptoms.
* History or risk of severe, chronic, untreated, or currently active autoimmune disease
* Prior solid organ transplant or has had an allogenic hematopoietic stem cell transplant within the past 20 years
* Pregnant, lactating, or breastfeeding