cyrilzakka/clinical-trials huggingface dataset:
Palbociclib in Real World Practice

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria

1. Age ≥18 years or older.
2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
3. Documented HR+ (ER+ and/or PR+) tumor based on local standards.
4. Documented HER2- tumor based on local standards.
5. Physician has determined that treatment with palbociclib is indicated.
6. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
7. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
3. Patients on active treatment for malignancies other than ABC at the time of enrollment.
4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.

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Ondansetron Treatment for Alcoholism

The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for alcohol dependence.
* Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder.
* Understand the requirements of the study and be able to complete the questionnaires and rating scales.

Exclusion Criteria:

* Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study.
* Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines.
* Receiving current psychotropic medications.
* Current history of other psychiatric disorders excluding nicotine dependence.
* Hepatocellular disease.
* Pregnant females.
Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU

Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 800 parents and their babies, who are expected to stay at least 5 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.


Eligibility Criteria:
Inclusion Criteria:

* Parents who have an infant admitted to the NICU
* Parents who provide consent to participate within 7 days following birth
* Infant (regardless of gestational age or diagnosis) is anticipated to have at least a 5-day NICU stay

Exclusion Criteria:

* Parents who are unable to read or write English
* Parents whose infant is not anticipated to survive within the 7-day enrollment period after birth based on attending physician assessment
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery

Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.

Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class 1,2
* Expected surgical time between 2 - 6 hours
* Scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

* Severe dysfunction of liver, heart, kidney, or lung
* Cannot understand numeric rating scale of pain
* Known or suspected allergy to oxycodone
* Previous history of postoperative nausea or vomiting
* Medication of antidepressants
* Postoperative long-term ICU care or prolonged mechanical ventilatory support
* Chronic pain
* Drug abuser
* Hypersensitivity reaction to aspirin or NSAIDs
* Refuse to enroll
Home-based Cycling for People With Lumbar Spinal Stenosis

The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly impairs functioning and health-related quality of life of elders, and has an important healthcare cost.

The 2 main treatment options for lumbar spinal stenosis are conservative or surgical treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.

The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 50 year-old
* radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
* MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology

Exclusion Criteria:

* inability to speak and/or read French language
* inability or refusal to perform ergometric bicycle at home
* patients already having an ergometric bicycle at home
* history of lumbar spine surgery in the previous 12 months
* cognitive disorders
* severe neurologic or vascular disorders involving the lower limbs
* contraindication to a rehabilitation program assessed by medical examination
* people under tutorship or curatorship
* protected adults
In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

Depression is one of the most common perinatal complications, with 1 in 7 mothers qualifying for a diagnosis of postpartum depression (PPD) and even higher rates for those who identify as Hispanic/Latine, Black or African American, American Indian, or Alaska Native, or by multiple races or ethnicities. This project addresses this major gap in services to prevent PPD, particularly among socioeconomically disadvantaged and minoritized groups. It tests the benefit of a virtual perinatal preventive intervention in English and Spanish to increase access, scalability and address the mental health needs of underserved populations. This project will test the virtual version against the in-person version of a service-ready efficacious preventive intervention in a randomized controlled trial (RCT). This trial will provide a test of a preventive intervention with a strong evidence base that is scalable and can be delivered with fidelity by service providers in settings where obstetric care is received. In this project, pregnant women will be randomized to receive an evidence-based group prevention program (Reach Out, Stay Strong, Essentials for New Moms; ROSE) designed for perinatal populations either a) in person, delivered at the hospital where they are receiving prenatal care or b) virtually, delivered by the same staff via video conferencing, both offered in English and Spanish. Diverse pregnant individuals (N = 900) will be randomized to receive virtual or in-person ROSE. The central outcome, depression, will be assessed via REDCap surveys, prenatally (before the program begins and at the end of gestation) and postpartum (approximately six-weeks, 3, 6, and 12-months after birth). Electronic health records (EHRs) and surveys will be used to examine obstetric, mental health (e.g., standard of care depression screening), and sociodemographic factors linked to health disparities that may impact who benefits most.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Less than 30 gestational weeks

Exclusion Criteria:

* None
Epidemiology of Chronic Pain as Part of the Post-intensive Care Syndrome

Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.

Post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. These chronic health issues bear tremendous burden for patients and next-of-kin. Among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. In the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. The investigators have addressed these patients to pain care specialists, with successful treatment success. However, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. The incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge.

The aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. The investigators intend to describe the incidence of chronic pain assessed with a Simple Verbal Score ≥ 3, 3 months after the ICU admission. The investigators also intend to describe the incidence of painful symptoms, at ICU discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the ID-Pain scale. The evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. The investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis.

The investigators are performing a nation-wide multicentric study. At this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria :

* All patients admitted in ICU
* ICU length-of-stay ≥ 48 hours
* No major cognitive impairment that could prevent pain evaluation

Exclusion Criteria :

* Patient under 18-year-old
* Patient under guardianship
* Patient unable to communicate or quantify pain with a Verbal Score and ID-Pain score
* Refusal to participate
Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey

Introduction: Machine perfusion (MP) was developed to expand the available donor pool and to improve liver transplantation outcomes. Despite optimal results in clinical trials, MP benefit outside of clinical experimentation in unknown. Low/mid volume centres (L/MVCs) may face logistical/economical difficulties that may in turn hamper optimal MP results.

Methods: An Online 22-item survey on the use of machine perfusion for liver transplantation outside of clinical trials, was distributed to worldwide LT centres representatives. Variables of interest included MP logistics, MP technicalities, MP results, post-MP LT results. Responding centres were grouped into high volume centre (HVCs)(defined as \>60 LTs per year in 2019) and L/MVCs. Results from HVCs vs L/MVCs were compared.


Eligibility Criteria:
Inclusion Criteria:

* LT centres that use MP
* LT centres which perform LT before pandemic time (before 2019 included)
* LT centres which perform LT from cadaveric donors and living donors

Exclusion Criteria:

* LT centres that not use MP
* LT centres that use MP but on clinical trials
Prognostic Model of Hypertension

The aim of this study was to establish a registration and monitoring system for hypertension in Xinjiang from 2020 to 2030 to obtain real information about patient basic information, patient characteristics, diagnostic test patterns, treatment options, and hospitalization outcomes (including mortality). Treatment complications, hospitalization costs, and end-of-life events (death, major adverse cardiac events, mild adverse cardiovascular events) in patients with hypertension in Xinjiang; and scientific prevention strategies aimed at effectively preventing the onset of hypertension; Guidelines in clinical practice recommend, analyze and develop effective treatment strategies to optimize management and outcomes for patients with hypertension; and create cost-effective assessment systems.

The aim of the study is to establish a platform for monitoring, clinical research and translational medicine in Xinjiang, which aims to provide a basis for future quality improvement and research, and to promote efforts to improve the prognosis of patients with hypertension, and to translate research into improved care for patients, thereby reducing Morbidity and mortality associated with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* A patient diagnosed with primary hypertension who was admitted to the First Affiliated Hospital of Xinjiang Medical University

Exclusion Criteria:

* Patients with secondary hypertension, patients with liver and kidney dysfunction,
* patients with mental disorders, and patients who are unwilling to participate in this trial
Sedation of Morbidly Obese for Balloon Insertion

This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.


Eligibility Criteria:
Inclusion Criteria:

* morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of OnabotulinumtoxinA for the treatment of male participants with PE. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).

Eligibility Criteria:
Inclusion Criteria:

* History of premature ejaculation
* Stable monogamous sexual relationship with female partner for at least 6 months, and intends to continue with the same partner for the duration of the study
* Participant has ability to follow study instructions and complete study assessment tools

Exclusion Criteria:

* Premature ejaculation caused by medical or surgical issues, or is related to stress or other issues (eg, relationship problems)
* Pain with ejaculation
* Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or penile injections during the study
* Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision)
* Previous or current usage of botulinum toxin therapy of any serotype for any urological condition
* Use of botulinum toxin therapy of any serotype for any nonurological condition (eg, cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage during the study
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
* Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
* Patients with single large HCC or multinodular HCC

  * Single \& 5cm \< size \< 15cm
  * 2-5 nodules \& maximal sized 4-15cm \& sum of diameters ≦ 25cm
  * Infiltrative type \& unilobular involvement on liver MRI
  * Segmental or lobar portal vein invasion can be included.
* Age : 20 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  * WBC count ≧ 1,000/mm3
  * Absolute neutrophil count \> 500/mm3
  * Hb ≧ 7.0 g/dL
  * Platelet count \> 100,000 /mm3
  * Bilirubin ≦ 3 mg/dL
  * Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion Criteria:

* Child-Pugh score ≧ 8
* ECOG Performance Status ≧ 3
* Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
* History of organ allograft
* Patients with uncontrolled co-morbidity which needs treatment
* Patients who have received prior systemic chemotherapy
* Patients who have received Capecitabine within 8 weeks
* Patients with extrahepatic metastasis
* Main portal vein invasion
* Patients with lymph node metastasis
* Bilobar involvement
* Bulk disease(Tumor volume \>70% of the target liver volume, or tumor nodules too numerous to count)
* Pregnancy