cyrilzakka/clinical-trials huggingface dataset:
18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer

This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer.

Study Hypothesis:

FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.

Up to 60% of patients treated with radical prostatectomy or external beam radiotherapy for prostate cancer will have biochemical failure at 5 years. This may be due to several reasons, including presence of sub-clinical metastases at time of local therapy.

Currently, patients with high risk prostate cancer are staged by MRI of the prostate (to assess local extent of disease), CT of the abdomen(to detect spread to lymph nodes) and bone scan (to assess for spread to bones). However, these standard imaging exams do not always identify all sites of disease. Recent research has suggested that performing positron emission tomography (PET) scanning with a tracer called fluorocholine (FCH) improves identification of lymph node and bone metastases in prostate cancer, resulting in more accurate diagnosis.

The main goal of this study is to find out whether staging high risk prostate cancer patients with FCH PET-CT and MRI of the whole body will improve detection of primary tumors and metastases compared to current standard imaging exams. Improved staging of patients with prostate cancer may impact patient care as it will help to select more appropriate therapy.

In this study, participants will undergo either combined PET/MRI or PET-CT and MRI after standard evaluations. The accuracy of each staging approach (standard vs. PET and MRI) will be evaluated. In addition, we will incorporate novel methods for data interpretation by creating imaging maps combining data from PET and MRI (termed "Multiparametric maps"). The goal of this novel approach is to find out whether mapping 2 or more characteristics of a tumor at the same time will improve tumor detection and accuracy of diagnosis.

About 40 men from the Princess Margaret Hospital will take part in this study. The study should take about 2 years to complete enrollment and the results should be known within 36 months of completion of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologic diagnosis of carcinoma of prostate
* High risk disease: defined as Gleason ≥8, or T3 disease, or PSA \>20ng/mL
* No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy).
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Prior surgery or radiation therapy for prostate cancer
* Prior or ongoing hormone or other systemic therapy for prostate cancer
* Inability to lie supine for 90 minutes
* Any contraindication to MR as per Joint Department of Medical Imaging policies.
* Impaired kidney function with glomerular filtration rate \< 30ml/min
* Previous anaphylactic reaction to gadolinium or other contraindications to MR.
Charcoal in Lung Cancer Patients Undergoing TEMLA

This proof-of-concept study serves as the preliminary step to prove safety of oral activated charcoal (OAC) in patients with solid tumors before moving to a hematologic malignancy patient population.

TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) is a procedure for mediastinal lymph node sampling to stage patients with lung cancer. All patients receive a dose of IV antibiotic pre-procedure to prevent infection. The concept of the proposed study is to protect the gut microbiome against detrimental effects of the antibiotic using oral activated charcoal as a potent adsorbent with no absorption. Oral activated charcoal (OAC) binds to the fraction of IV antibiotic that reaches the lumen of the gut without interfering with its desired systemic effects. The conceptual goal is to prevent dysbiosis by protecting the gut microbiome. Dysbiosis is the leading cause of C. difficile infection and a number of other adverse clinical outcomes such as antibiotic resistance.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed diagnosis of lung cancer (non-small cell lung cancer, small-cell lung cancer or neuroendocrine tumor) for which a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is planned
* Planned pre-procedural IV antibiotic. The choice of antibiotic type is up to the treatment physician(s)
* Able to safely hold all oral medications on the day of surgery and the day after to ensure the absorption of such drugs is not affected due to charcoal ingestion the night before surgery
* 18 years of age or older
* Able to provide written consent prior to any research related activities

Exclusion Criteria:

* Current pregnancy or breastfeeding (SOC pre-TEMLA testing/assessment)
* Any current diagnosed disease with known involvement of the gastrointestinal tract
* Known allergy to oral activated charcoal
* CTCAE v 5 Dysphagia Grade 2 (symptomatic and altered eating/swallowing) or greater
* Known risk of aspiration based on history or current complaints
* Gastrointestinal procedures within 2 weeks before or (planned) after TEMLA
* Systemic antibiotic use within 8 weeks before planned TEMLA
A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

The purpose of this study is to:

* evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.
* evaluate and compare the adverse event profile in all groups.

Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.

This is a single-center study performed in an interventional pain management referral center in the United States.

The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.

Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value \< 0.05.

Eligibility Criteria:
Inclusion criteria:

* Patients with history of lumbar surgery of at least 6 months duration in the past
* Patients over the 18 years of age
* Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration
* Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements

Exclusion criteria:

* Post surgery, central spinal stenosis, and facet joints as sole pain generators
* Unstable or heavy opioid use
* Uncontrolled psychiatric disorders
* Uncontrolled medical illness
* Any conditions that could interfere with the interpretation of the outcome assessments
* Pregnant or lactating women
* Patients with a history or potential for adverse reaction(s) to local anesthetics or steroid.
A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC

To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC

Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old male or female
2. Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
3. Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
4. EGFR positive in blood or tissue tested in local laboratory;
5. Sufficient blood samples can be provided for molecular detection;
6. Signed informed consent forms are available.

Exclusion Criteria:

1. Patients were unable to collect plasma samples at baseline;
2. The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
3. The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.
a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® in the Treatment of Hypertensive Emergency and Sub-emergency

This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years-old and ≤75 years-old, regardless of gender;
2. Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
3. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

Exclusion Criteria:

1. Patients with known severe lipid metabolism disorders;
2. Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent;
3. Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
4. Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
5. Patients with clear history of secondary hypertension;
6. Patients with other serious large organ damage or serious complications, it may threaten life;
7. Known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients;
8. Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs;
9. Patients who cannot tolerate intravenous infusion therapy for at least 6 hours;
10. Pregnant and lactating women or patients who plan to have a family during the trial period;
11. Patients who have participated in other interventional clinical trials within 3 months prior to screening;
External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes

The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:

Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.

Participants will:

Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.

Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.

Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Diagnosed with recent (\<1 week) intra-articular distal end radius fractures.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Open fractures classified as Gustilo grade II or higher.
* Fracture avulsion or dislocation.
* Vascular injury associated with the fracture.
* Extra-articular fractures of the distal radius.
* Preexisting joint or carpal bone disease affecting rehabilitation.
* Patients unwilling to provide consent.
A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking

The purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety.

Investigators will develop a culturally adapted, brief, single-session PFI delivered via a mobile health application for the Android and iOS platform through an iterative approach using expert input and semi-structured interview sessions. Next, Black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Black hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. Initial screening will be conducted via Zoom; baseline and post-treatment data will be collected via Zoom and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

Eligibility Criteria:
Inclusion Criteria:

* Being 21 years of age or older
* Self-identifying as Black or African American
* Meeting criteria for current hazardous drinking pattern
* Meeting criteria for clinical anxiety
* Being able to provide written, informed consent
* Owning a smartphone.

Exclusion Criteria:

* Current participation in alcohol or other substance abuse treatment
* Engaged in psychotherapy for anxiety or depression
* Concurrent use of medication for anxiety or depression
* Being pregnant by self-report
* Residence outside of the United States confirmed via survey geolocation
* Inability to provide a valid United States-issued driver's license or identification card to verify identity.
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.


Eligibility Criteria:
Inclusion Criteria:

* Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
* Presence of active plaque psoriasis with a BSA ≥3%
* 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 had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Exclusion Criteria:

* Current or prior use of biologic agents for treatment of Ps or PsA
* Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Active Crohn's disease or active ulcerative colitis
* Active vasculitis or uveitis
* Diagnosis of or history of malignant disease \<5 years prior to randomization
* Women who are breastfeeding
Modified Rapid Sequence Induction in Morbidly Obese Patients

This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.

100 adult patients with a body mass index \> 40 undergoing elective laparoscopic surgery will be included. Patients with a history of previous bariatric surgery or with an anticipated difficult airway will be excluded.

The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.

All groups will receive standardized preoperative continuous positive airway pressure (CPAP) therapy.

In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed after 1 minute. No bag mask ventilation will be performed in-between.

Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3 minutes. The same induction agents as in group one will be administered. PEEP via facemask will be continued for one minute and tracheal intubation will be performed.

Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with additional pressure support of 8 mbar and a back up ventilation frequency will be set to 10/min. After the same induction agents are given as in group 1, patients will receive non-invasive ventilation via ventilator at the settings described earlier for group 3.

Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be applied during the non invasive ventilation.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40
* American Society of Anesthesiology Class 1-3
* Elective laparoscopic surgery

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Previous bariatric surgery
* Anticipated difficult airway
Behavioral Activation for Dementia Caregivers

This project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers.

The study compared two telephone interventions using a four-month longitudinal randomized controlled trial. For the first four weeks, all participants received the same psychoeducation program via telephone. Then for the following four months, eight biweekly telephone follow-up calls were carried out. For these eight follow-up calls, participants were randomized into either one of the two following groups with different conditions. For the Psychoeducation with BA (PsyED-BA) group, participants would receive eight biweekly sessions of BA practice focused on pleasant event scheduling and improving communications. For the Psychoeducation only (PsyED Only) group, there would be eight biweekly sessions of general discussion of psychoeducation and related information

Eligibility Criteria:
Inclusion Criteria:

They were caregivers aged 25 or above and must have be caring for a care recipient diagnosed with Alzheimer's disease for at least 3 months. They should be the primary caregiver and a spouse, kin (e.g. daughter/son or daughter/son-in-law) or sibling of the care recipient.

Exclusion Criteria:

To ensure intervention fidelity, participants who showed signs of severe intellectual deficits, demonstrate suicidal ideation, exhibit evidence of psychotic disorders, or cannot read or speak fluent Chinese / Cantonese were excluded.
Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients

The purpose of this study is to evaluate of efficacy and safety of HCP1904-2 and RLD2001-2 alone in patients with essential hypertension inadequately controlled on RLD2001-2 monotherapy.

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age
2. Patients who understands the process of clinical study and voluntarily signs a peer letter
3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

   * Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
   * Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
4. Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg

Exclusion Criteria:

* Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
* Orthostatic hypotension with symptoms within 3months of visit 1
* Secondary hypertensive patient or suspected to be
* Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
* Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
* Severe heart disease or severe neurovascular disease
* Severe or malignant retinopathy
* Clinically significant hematological finding
* Severe renal diseases (eGFR\<30mL/min/1.73m2)
* Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
* Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
* Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
* Hypercalcemia
* History of malignancy tumor
* History of autoimmune disease
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Subjects with diabetes risk score ≥ 15
* Subjects with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \< 1 .26 g/L
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Fasting glycemia ≥ 1.26 g/l
* Fasting glycemia ≤ 1.10 g/l
* Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV, GLP-1 R agonists.
* Subjects previously treated with insulin, except gestational diabetes
* Severe coagulation disorders
* Thrombocytopenia \< 100 000/mm 3
* Severe psychiatric disorders
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe hepatic insufficiency (TP \< 50%)
* Alcohol abuse (\> 30g/j)
* Patient's opposition
* Subject unable to follow the study during the 5 years of follow-up
* Subject exclusion period in a previous study