cyrilzakka/clinical-trials huggingface dataset:
Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer

This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

PRIMARY OBJECTIVES:

I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.

II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.

OUTLINE:

Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Any ethnic group
* Pathologically proven prostate cancer with high risk for bone metastases
* Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA \> 10 ng/mL
* Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
* Patients Eastern Cooperative Oncology Group (ECOG) performance is =\< 1

Exclusion Criteria:

* Patients may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration
* Patients with known contraindications to MR imaging such as presence of MRI incompatible devices such as pacemakers and certain aneurysm clips, severe claustrophobia, or any other condition which would preclude proximity to a strong magnetic field; this exclusion is a standard of practice
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
* Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET
Increased Rate of Prophylaxis Against Venous Thromboembolism Due to eAlerts

Now, after a cluster randomized controlled trial, eAlerts providing evidence-based guidelines on venous thromboembolism prophylaxis will be rolled out and evaluated hospital-widely.

An eAlert is displayed in the electronic patient chart if no prophylaxis has been ordered within 6 h after admission or transfer. The eAlerts provide evidence-based guidelines on venous thromboembolism prophylaxis. Now, after a cluster randomized controlled trial, the eAlerts will be rolled out and evaluated hospital-widely.

Eligibility Criteria:
Inclusion criteria:

* all in-patients hospitalized in a ward with computerized physician order entry (CPOE),
* staying at least 24 h in a ward

Exclusion criteria:

* outpatients,
* ward without CPOE,
* patients transferred from an intervention to a control ward and vice versa
Effects of Mindfulness Training on the Psychological Well-being of Preschoolers

The present study is a randomized controlled trial to evaluate the effectiveness of a mindfulness course on the psychological well-being of preschoolers (i.e., attention and impulsivity, prosocial behavior, empathy, emotion regulation and conduct). Participants will be randomized to either intervention (dots Curriculum) or wait-list control condition. Participants will complete a computerized task and they will be interviewed to complete a scenario test before (baseline) and after the intervention. The parents and class teacher will also be invited to complete a survey at baseline and after the intervention.


Eligibility Criteria:
* Aged 3-6 years
* Studying in pre-school settings
Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis

OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet.

II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.

PROTOCOL OUTLINE: Following a 2-week baseline assessment, patients participate in a feeding study for up to 3 weeks. The diet is free of cholesterol and cholestanol.

For the next 4 weeks, patients return to their typical diet and are medicated with daily lovastatin and chenodeoxycholic acid.

The feeding study is repeated for an additional 3 weeks, with the patient taking either lovastatin or chenodeoxycholic acid.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis
Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN

The study is evaluating an intervention consisting of a five week online mindfulness program for patients being referred to the Pain Clinic and triaged to eConsult. A pain specialist will be in contact with the patient's family physician to confirm it's appropriate and then a therapist will initiate contact with the patient to assess eligibility. The therapist will be a registered health professional with experience with patients with chronic health problems and will be supporting the online program where the participant will have communication access to them. Questionnaires will be sent at three time points to assess changes.

There are currently many patients waiting to be seen at The Ottawa Hospital Pain Clinic (TOHPC). However, many patients with chronic pain (CP) have exhausted medical options or could be served in the community with appropriate support for them and their family physicians (FPs). eConsult is a secure web-based platform that allows TOHPC physicians to provide pain management advice within seven days within the Champlain Local Health Integration Network (LHIN).

In order to provide enhanced care to patients and improve the uptake of eConsult for CP, the investigators have developed a shared care model for CP in the Champlain LHIN. This program combines the use of eConsult for FPs and a 5-week self-directed online CP management program with therapist support available as needed.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-years or older
* ability to understand oral and written English
* report chronic pain (≥3months)

Exclusion Criteria:

* refusal or inability to provide informed consent
* severe, unstable or untreated psychiatric conditions (ex. severe depression, psychosis, bipolar, etc.)
* does not have access to the internet or electronic device capable of watching videos
Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects

This is a phase I, open-label, fixed-sequence study in healthy Chinese subjects, performed at a single study centre. Cohort A will assess the Pharmacokinetic (PK) profile of rongliflozin when administered alone and the combination with rifampicin; Cohort B will assess the PK profile of rongliflozin when administered alone and combination with probenecid.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions;
* Be able to complete the test according to the requirements of the protocol;
* Subjects (including partners) are willing to take effective contraceptive measures from screening to 6 months after the last dose of drug administration;
* Male subjects weigh at least 50 kg and female subjects at least 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI within the range of 18 to 28 kg/m2 ;
* Physical examination and vital signs are both normal or do not have clinical significance.

Exclusion Criteria:

* Smoking more than 5 cigarettes per day;
* Those who are allergic to or have allergies to the test drug;
* have a history of drug or alcohol abuse;
* Blood donation or massive blood loss (\>450 mL) within three months prior to screening;
* Difficulty swallowing or any history of digestive system diseases which could affect drug absorption and excretion within 6 months before screening;
* taking any drugs that could alter liver enzyme activity, such as barbiturates, rifampin, etc., within 30 days before screening;
* have taken any prescription, over-the-counter, vitamin product or herbal medicine within 14 days prior to screening;
* Have taken special diets (including dragon fruit, mango, grapefruit, etc.) or exercised strenuously within 2 weeks before screening;
* Take an inhibitor or inducer of glucuronide transferase (UGT), P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP), such as itraconazole, ketoconazole, or dronedarone, within 30 days before screening;
* Significant changes in dietary or exercise habits within 2 weeks prior to screening; Female subjects are breastfeeding or have a positive blood pregnancy result during the screening period;
* During the screening period, the serum uric acid level was \>420 µmol/l, or had a history of gout; during the screening period, the estimated glomerular filtration rate (eGFR) was \<90 ml/min/1.73m2) or had a history of kidney stones or bladder stones (applicable to Cohort B);
* have a clinically significant laboratory tests or medical history;
* Positive for hepatitis B, hepatitis C, AIDS, syphilis; positive for urine drug test;
* History of urinary tract infection or genital infection before 6 months
* Those who participated in any drug clinical trial and used the experimental drug 3 months ago;
* Subjects with other factors deemed inappropriate by the investigator.
Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.

Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic range) in combination with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors.

Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1)
* Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a)
* Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions \> 2 units packed red blood cells every 3 months)
* Ability to swallow and retain oral medication

Exclusion Criteria:

* Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
* Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
* Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment or ongoing radiotherapy-related toxicities.
* Presence of ≥ Grade 2 neuropathy.
* Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
* Recent (≤ 3 months) history of partial or complete bowel obstruction.
* Unwillingness to be transfused with blood components.
* Known history of Hepatitis B or C infection or HIV infection
Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.

This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.

Eligibility Criteria:
Inclusion Criteria:

* chronic pain for \>6 months
* history of taking daily opioids for pain for \>6 months
* average \>3 on a pain intensity scale of 0 to 10 over past week
* able to speak and understand English
* chronic neck or back pain as primary pain complaint
* willingness to participate

Exclusion Criteria:

* current opioid addiction (M.I.N.I. Section K)
* current diagnosis of cancer or any other malignant disease
* acute osteomyelitis or acute bone disease
* nonambulatory
* present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder
* pregnancy
* any clinically unstable systemic illness judged to interfere with treatment
* an acute condition requiring surgery
* taking opioids intermittently
Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB) and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, in this study, the analgesic efficacy of two different methods, DSAPB and SSAPB, will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Patients with bleeding disorders
* Emergency surgery
Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes

This study is conducted in Asia, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents with type 1 diabetes mellitus
* After the participating physician's decision has been made to initiate treatment with NovoPen Echo®, any patient who meets all the inclusion criteria and does not meet any of the exclusion criteria, is eligible to participate
* Use of insulin pen or syringes for at least 12 months

Exclusion Criteria:

* Insulin pump or Insuflon® users
* Any disease or condition in children/adolescents which might interfere with the study at the individual physician's discretion
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must give a written, signed and dated informed consent.
2. Men or women at least 18 years of age at time of screening.
3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
4. Moderate to severe psoriasis as defined at Baseline by:

   * PASI score of 12 or greater, and
   * IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
   * Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

   * topical treatment and/or,
   * phototherapy and/or,
   * previous systemic therapy.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
2. Drug-induced psoriasis.
3. Ongoing use of prohibited treatments.
4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

The purpose of this study is to:

Compare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.

Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.

All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* acute (\<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity \>3 on a visual numeric scale

Exclusion criteria:

* open fracture
* head, abdominal, thoracic or polytrauma.
* Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED
* history of allergy or hypersensitivity to either paracetamol or NSAIDs,
* contraindication to paracetamol or NSAIDs,
* acute /history of GI hemorrhage and renal insufficiency,
* an inability to assess pain intensity according to the VNS.
* Pregnancy
* heart failure
* known hepatic cirrhosis
* known severe renal impairment (Creatinine clearance \<30 ml/min)
* swallowing disorders
* Refusal, incapacity or difficulties to consent or to communicate
Individual and Group Exercise Program for Industrial Workers With CANS: Randomized Controlled Trial

This study is double-blinded RCT, whose aim is to assess if an individual exercise program is more effective to reduce complaints in neck, shoulders and arms that an group exercise program, in industrial workers.

The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care.

This study is double-blinded RCT. Participants will be recruited from employees of the companies and industries located in the South of Bahia, Brazil or by referral from general practitioners, orthopedists, This study is single-blinded RCT, whose aim is to assess the efficacy of an individual exercise program for employees with complaints in neck, shoulders and arms. Participants will be recruited from employees of the companies and industries located in Brazil or by referral from general practitioners, orthopedists, neurologists or physiatrists.

The sample of 100 participants was determined by a sample size calculation designed to detect a clinically important difference of 10 points in the DASH Questionnaire (estimated standard deviation = 16,65 points). The following specifications will be considered: α=0.05, statistical power of 80% and follow-up loss of up to 15%.

The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnose of nontraumatic complaints of the arm, neck or shoulder with minimum intensity of 4 points on the visual analogue pain scale1, for at least 6 weeks2.

Exclusion Criteria:

* Participants with contraindication to physical exercise
* Participants who had been diagnosed with cervical disc hernia; shoulder instability; fractures; frozen shoulder; systemic diseases such as rheumatoid arthritis or diabetes; neurological diseases or other severe medical or psychiatric disorders