cyrilzakka/clinical-trials huggingface dataset:
Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer

RATIONALE: A computer program and education materials may help improve the ability of doctors to communicate with patients.

PURPOSE: This randomized clinical trial is studying how well a computer program together with education materials works in improving communication between doctors and patients with stage IV cancer.

OBJECTIVES:

Primary

* Determine the impact of a CD-ROM-based intervention in improving communication behaviors between oncologists and patients with stage IV cancer.
* Compare the quality of audio-recorded conversations between oncologists and patients with advanced cancer with best practices described in the literature, with particular attention to communication behaviors that promote patient disclosure of concerns, use of emotion handling skills, recognition of empathic opportunities, and the conveying of prognostic information and compare.
* Develop an intervention to improve oncologists' communication skills in these areas using an interactive CD-ROM based on the oncologists' own recorded discussions with patients.
* Determine the feasibility of this intervention and, using a randomized, controlled design, measure its effectiveness for changing physician communication behaviors and relevant patient outcomes including reduced distress and increased satisfaction.

OUTLINE: This is a randomized, controlled, 3-part, multicenter study.

* Part 1 (baseline): Patients undergo an audio-recorded outpatient encounter with their oncologist to see how oncologists elicit patients' concerns and respond to emotional content. Within 1 week later, patients undergo a 10-minute interview by telephone.
* Part 2 (intervention): Oncologists are randomized to 1 of 2 arms.

  * Arm I (intervention): Oncologists receive a personalized, user-friendly CD-ROM that contains their coded conversations, packaged with related educational material to be used for 3 months.
  * Arm II (control): Oncologists do not receive a CD-ROM or any other educational material support.
* Part 3 (post-intervention): Three months later, oncologists in both arms are reassessed by recording another 400 clinic visits between the same oncologists and a new group of patients to measure the intervention impact.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of advanced cancer (stage IV disease) AND meets all of the following criteria:

  * Referred by participating physician
  * Must speak English
  * Receiving primary oncology care at participating centers, defined as at least 2 visits to the clinic during the past year and a future scheduled appointment
  * Receiving treatment for any malignancy
  * Has access to a telephone

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment

For patients of GIST (Gastrointestinal Stromal Tumor), Imatinib has been widely used in GIST with KIT or PDGFRA sensitive mutations. From clinical points of view, individual differences often occur between different patients, leading diverse effect in ADR and drug effect. Meanwhile, the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic and other factors. In this research, we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations, plasma trough concentration and drug effect, the association between ADME-associated SNP, Target/Receptor/Pathway-associated SNP, trough concentration and TKI adverse effect. Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

The plasma concentration of Imatinib were established. The ADME-associated SNPs included are CYP3A4, CYP3A4, CYP1A1, CYP2C9, CYP2C19, ABCB1, ABCG2, ABCC4, SLC22A1, SLCO1B3 and so on. The Target/Receptor/Pathway-associated SNP s included KIT, PDGFRA, PDGFRB, FLT1, FLT3, MAPK1, SHC1, CCL5, CXCL14 and so on. The somatic mutations included are KIT, PDGFRA, BRAF and so on.

Eligibility Criteria:
Inclusion Criteria:

* The main patient entry criteria included: age≥ 18 years; histologically and cytologically proved GIST; Eastern cooperative oncology group performance status (ECOGPS)≤2; adequate hematological,renal,and hepatic functions.

Exclusion Criteria:

* uncontrolled systemic disease,and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.
Observational Study of the Value of Using Obstructive Sleep Apnea-hypopnea Syndrome (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.

The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the general population. It also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old and naive to any treatment with obstructive sleep apnea-hypopnea syndrome,
* Patients at high risk of obstructive sleep apnea-hypopnea syndrome (STOP BANG ≥ 3),
* Patients scheduled for major abdominal surgery (all intraperitoneal surgeries excluding vesicles, eventrations and hernias, all aortic surgeries excluding endovascular surgeries) within a minimum of 10 days,
* It is possible to integrate the explanations concerning the realization of the ApneaLink ™ Air in autonomy and to ensure its restitution under 24-48h,

Exclusion Criteria:

* Patients with obstructive sleep apnea-hypopnea syndrome diagnosed before surgery,
* Patients with heart failure (NYHA\> II),
* Patients with moderate to severe COPD
* Patients participating in a clinical trial,
iCanCope With Sickle Cell Pain

The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.

Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* aged between 12-18 years
* diagnosed with any type of SCD
* able to speak and read English
* score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
* willing and able to complete online measures

Exclusion Criteria:

* significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
* have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients

The present research was aimed at comparing the effects of Cognitive Processing Therapy (CPT) with the effects of Sertraline in treating patients who have dual diagnosis PTSD \& SUD. The present study examines the extent to which CPT is effective in treating PTSD symptoms for patients with PTSD and SUD.

Patients with co-occurrence PTSD \& SUD disorders were grouped into 3 groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: were treated by Sertraline. Third: a placebo control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with SUD

Exclusion Criteria:

* Patients diagnosed with other psychotic disorders
The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)

The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).


Eligibility Criteria:
Inclusion Criteria:

* Have completed a patisiran study (i.e., completed the last efficacy visit in the parent study) and, in the opinion of the investigator, tolerated study drug
* Be willing and able to comply with the protocol-required visit schedule and visit requirements and provide written informed consent

Exclusion Criteria:

* Any new or uncontrolled condition that could make the participant unsuitable for participation
Training for Injury Prevention in Collegiate Soccer Players

The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.

The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve and injury incidence rate will decrease after participation in an intervention aimed at restoration/refinement of sensorimotor control. This study will be conducted as a 1-arm intervention with pre- and post-participation measurement of sensorimotor control and completion of an exercise intervention. Statistical analyses will be completed to determine within group change pre-to post-intervention and injury risk by comparing injury rate in 2018 to injury rate of a historical control.

Eligibility Criteria:
Inclusion Criteria:

* Male and female athletes on the soccer roster who are eligible to play in the fall 2018 season at Mississippi College

Exclusion Criteria:

* Any athlete who has a current diagnosis of concussion (i.e. a non-medically cleared concussion), lower-extremity musculoskeletal injury, or other medical diagnosis that will prevent the athlete from participation in the intervention.
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.


Eligibility Criteria:
Inclusion Criteria:

For SAH group:

* Alcohol consumption :

  * On average\> 40 g / day for women and 50 g / day for men
  * Duration:\> 5 years
* Recent jaundice episode (less than 3 months)
* Bilirubin\> 50 mg / l (85μmol / l)

For NSAH group:

- Alcohol consumption :

* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years

For cirrhosis (control) group:

* Alcohol consumption :

  * On average\> 40 g / day for women and 50 g / day for men
  * Duration:\> 5 years
* Unambiguous presence of cirrhosis criteria, including:

  * clinical signs (ascites, stellar angiomas ...) and / or
  * radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or portal hypertension) and / or
  * biological signs (increased INR, thrombocytopenia) and / or
  * endoscopic signs (oesophageal / gastric varices)

Exclusion Criteria:

For NAH and NSAH groups:

* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
* Presence of hepatocellular carcinoma
* HIV infection

For cirrhosis (control) group:

* History established / suggestive of HAA (Clinical, biological and / or histological criteria) in particular absence of jaundice episode
* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
* Presence of hepatocellular carcinoma
* HIV infection
Studying the Effects of Cannabis on Vasculature

Cannabis is commonly used globally. It is associated with psychiatric problems, but the effects on the cardiovascular system are unclear. In this project, the investigators plan to study the effects of cannabis on the cardiovascular system. This will be done by using a non-invasive test to measure blood vessel function and by using blood samples to measure inflammation. As a control for this project, the investigators would like to test the blood vessel function and inflammation levels of participants who do not use cannabis. This study will provide important information on the long term cardiovascular effects of cannabis.

Cannabis is the most commonly used illicit drug in the world, but the investigators do not know the long-term effects on the cardiovascular system in humans. The investigators have data from cell culture and small animal studies that cannabis is toxic to the cardiovascular system. Recently legalized in Canada, the long-term effects of cannabis use on the cardiovascular system may not be apparent for several decades. The purpose of this study is to test the effect of cannabis use on the vascular system. Using a non-invasive test of vascular function, the investigators would like to assess the effects of cannabis on chronic cannabis users. The investigators would also like to test if cannabis use by smoking and/or vaping causes adverse cardiovascular effects acutely. Lastly, the investigators would like to test blood from chronic cannabis users for inflammatory cytokines, which could further support our hypothesis that cannabis damages the cardiovascular system via inflammation.

Eligibility Criteria:
Inclusion Criteria:

* age: 19 to 80
* males and females
* all ethnicities
* cannabis use at least 3-4 times per week or more in the past 6 months (50 volunteers, experimental group)
* patients who do not use cannabis (50 volunteers, control group)
* no history of cardiovascular disease

Exclusion Criteria:

* that ingest cannabis containing cannabidiol (CBD)
* that are unable to provide a receipt for the cannabis product(s) they ingest
* that are unwilling to stop consuming soy products and/or genistein 48 hours prior to appointments.
TESTING -ON Post-Trial ObservatioNal Cohort Study

The primary aim of this study is to extend follow up of TESTING study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on End Stage Kidney Disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs other) and kidney function (eGFR above and below 60 mL/min/1.73m2).

In the original TESTING study, the median follow-up for full vs reduced dose cohort was 6.1 vs 2.5 years. We learned from the TESTING trial that the composite endpoints (ESKD, 40% reduction in eGFR or death due to kidney disease) tend to start occurring 2-3 years after randomization. At the time of overall study completion, most of the reported endpoints had occurred in participants from the initial, full-dose TESTING cohort. Although we found the effect of corticosteroid is consistent in both doses, longer follow up is required to confirm the beneficial effects on clinically important renal outcomes of the apparently safer reduced reduced-dose cohort, and to confidently compare the effects across doses. As the trial is assessing the effects of a time-limited 6-9-month period of steroids, a post-trial observation cohort study is a critical, cost and resource-efficient method of answering a number of key questions:

1. Is the apparent benefit of glucocorticoid sustained over long term follow-up?
2. Does a lower dose of steroids safely produce similar benefits on long-term kidney outcomes?

The primary aim of TESTING-ON is to extend follow up of TESTING study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on end stage kidney disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs other) and kidney function (eGFR above and below 60 mL/min/1.73m2).

The working hypothesis of TESTING-ON is that a 6-9-month course of oral methylprednisolone will lead to persistent benefits over a long period of time.

TESTING-ON is a post-trial observational study of those participants randomized into the TESTING trial who are still alive, haven't reached ESKD and didn't withdraw consent during the trial. Follow-up will continue for up to five years, with further ongoing follow-up should funding allow.

Eligibility Criteria:
Inclusion Criteria:

1) Only participants who were randomised into the TESTING trial

Exclusion Criteria

1. Participants who have reached kidney failure requiring maintenance dialysis or kidney transplantation during the TESTING trial
2. Participants who died during the TESTING trial
3. Participants who had withdrawn their consent during the TESTING trial
4. Participants who are unable to provide consent for some other reason
Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia

This study is designed in two parts. Part 1 will assess the safety and tolerability of different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can prolong pregnancy in women with pre-eclampsia.


Eligibility Criteria:
Key Inclusion criteria:

* Written informed consent was obtained before any assessment was performed.
* Women at 18 to 40 years of age with a pregnancy 28 weeks (0 days) and 33 weeks (+4 days) gestational age. Gestational age was based on mother's last menstruation; if last menstruation was unknown, an alternative method was used as applicable and was documented in the (electronic) Case Report/Record Form \[(e)CRF\].
* Women with a diagnosis of pre-eclampsia or superimposed pre-eclampsia requiring hospitalization. Pre-eclampsia was defined as new onset of hypertension (SBP ≥ 140 or DBP ≥ 90 mmHg) or gestational hypertension accompanied by proteinuria (\>= 0.3 g/24h) after 20 weeks of gestation. Superimposed pre-eclampsia was defined as chronic hypertension with new onset of proteinuria after 20 weeks of gestation.
* Reassuring fetal testing (cardiotocography and biophysical profile)

Key Exclusion criteria:

* Severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 110 mmHg) and /or those receiving anti-hypertensive treatment at time of randomization.
* Clinically relevant electrocardiogram (ECG) abnormalities at screening excluding those abnormalities commonly seen in pregnancy according to the Investigator.
* Symptoms indicative of severe pre-eclampsia or HELLP syndrome (Hemolysis, Elevated Liver enzymes, and Low Platelet count) for which immediate delivery of the baby may be indicated. Symptoms include persistent CNS symptoms (severe headaches, visual changes, altered mentation), persistent right upper quadrant or epigastric pain, nausea or vomiting, severe thrombocytopenia (\<100,000/mm3) and abnormal (\> 2X upper limit of normal) liver enzymes (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]).
* Eclampsia during current pregnancy, vaginal bleeding present at screening, abruptio placentae, oligohydramnios
* Current diagnosis of a seizure disorder that requires chronic medication.
* Pre-gestational diabetes (Type 1 or Type 2) with or without diabetic retinopathy. Diagnosis (previous or current) of gestational diabetes, regardless of treatment, was allowed
* Known allergy to magnesium sulfate or steroids.
* Multifetal gestation, known major fetal anomaly, intrauterine growth restriction (\<5th percentile).
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.


Eligibility Criteria:
Inclusion Criteria include:

* Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
* The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
* Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

* Subjects with rheumatoid arthritis or other inflammatory arthritis;
* Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
* Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
* Subjects with chronic constipation not related to opioid use;
* Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
* Subjects with a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.