cyrilzakka/clinical-trials huggingface dataset:
Financial Incentives for Smoking Cessation

The purpose of this study is to test the effectiveness of financial incentives for increasing long-term smoking cessation rates among employees at General Electric worksites throughout the United States.

Smoking is the leading cause of preventable mortality in United States, accounting for approximately 435,000 of the 2.4 million deaths each year in the United States. Most smokers make multiple attempts to quit smoking, but only 2-3% succeed each year. Smoking cessation programs have proven effective in helping smokers quit, but only about 5% of smokers enroll in smoking cessation programs each year.

Financial incentives have been shown to increase enrollment in smoking cessation programs and short-term quit rates, but have not been well tested as a mechanism for increasing long-term quit rates. The existing evidence suggests that they could be highly effective, particularly among heavy smokers and low income smokers. In addition, financial incentives for smoking cessation will likely be more cost effective than most covered health services and at least as cost effective as other recommended smoking cessation treatments.

This study is a two-arm randomized clinical trial of financial incentives for smoking cessation among a sample of 850 male and female smokers from GE Energy worksites throughout the U.S. Smokers will be randomized to receive either usual care (information about local community-based smoking cessation resources, coverage of prescription drugs and physician visits) or usual care plus a package of financial incentives that includes $100 for completion of a community-based tobacco cessation program, $250 for short-term smoking cessation at either 3 months or 6 months after randomization, and $400 for smoking cessation 6 months post-quit date (biochemically confirmed).

Eligibility Criteria:
Inclusion Criteria:

* Employees of General Electric at work sites in the United States
* Current smokers who report having smoked at least 5 cigarettes per day for the prior 12 months
* Age 18 or older

Exclusion Criteria:

* Current use of other tobacco products, such as chewing tobacco, pipes, or cigars
* Planning to leave General Electric within the next 18 months
Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population; (EKBB 236/13)

This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.

Most Emergency Departments (EDs) perform an initial risk stratification of patients, called Triage. Establishing a diagnosis is key for the administration of the appropriate treatment and the following disposition decision. The earlier and the more accurate the final diagnosis is established, the shorter the time to treatment and time to disposition, and thus, the more efficient the patient flow. New ways to improve diagnosis accuracy early on in patients' ED visits are needed. Although a great number of well validated and widely used triage systems exists, to this date no gold standard in triage risk stratification has been established. Most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints.

This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.

According to acuity patients undergo triage or directly proceed to the treatment unit. Patients awaiting triage will be approached by a member of the study personnel and will be verbally informed about the study. Afterwards, patients will be interviewed asking about their symptoms and their reason for presentation. Patients in need of immediate therapy will receive therapy before start of the interview. Following the interview, patients undergo routine triage.The physician performing initial triage will be asked to rate how ill patients appear to be using a numeric scale ranging from 0 (perfect condition) to 10 (extremely ill). Treating physician's will be asked to state their suspected diagnosis as well as differential diagnoses. Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting to the ED of the University Hospital Basel and awaiting triage

Exclusion Criteria:

* unwillingness to participate
* insufficient ability to communicate with the study personnel.
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression

The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.

Investigators will conduct a randomized controlled trial (RCT) at two large VA facilities, to establish the effectiveness and scalability of MOTIVATE, a remotely delivered behavioral intervention for older Veterans with comorbid musculoskeletal (MSK) pain and depressive symptoms. The central hypothesis is that MOTIVATE will improve important patient-centered outcomes among older Veterans with co-occurring MSK pain and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 and older
* English- speaking
* Self-reported MSK pain (include cLBP +/- radiating symptoms, OA, fibromyalgia) on most days for the past 3 months that interferes with daily activities
* Pain intensity that is 4+/10 on the numerical pain rating scale
* Pain interference threshold 5+ on PEG-3
* Depressive symptoms, 10+ on PHQ-9
* Capable of participating in home-based activity
* Interested in participating in a non-pharmacologic program

Exclusion Criteria:

* Aged 59 or less
* No telephone
* Not English speaking
* Unwilling to be randomized to either study arm
* Not interested in participating in a non-pharmacologic program
* Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen
* Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam
* Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA\* (resulting in inability to participate in physical activity intervention)
* Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries)
* Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)
Autonomous At Home with Occupational Therapy Support and Assistive Devices

The aim of the AUDACE study is to evaluate the 'Bien chez Moi 2.0' programme, to assess how, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions? The study assesses the impact on areas such as the degree of autonomy, the extent to which life goals are taken into account, the feeling of security at home, the use of hospital emergency services and the postponement of definitive institutionalisation in a nursing home. The expected results of this study are to be able to robustly describe the impact of the 'Bien chez moi 2.0' programme in the areas listed above.

Background The BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place. The investigators designed the AUDACE evaluation to improve understanding of the programme and its effectiveness, and to promote a favourable context for the professional empowerment of occupational therapists as primary care providers.

Methods The investigators involved home care occupational therapists at every stage of the protocol design to ensure that the tools, training, and organisational structures put in place for the evaluation could also form the basis of their routine practice, harmonising their practices, ethos and processes.

The investigators designed a realist mixed methods evaluation to answer the following question: "How, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions?" Interrelated components addressed different research sub-questions: (1a) To describe the evaluation population, interventions, and contexts: a descriptive quantitative study using baseline data from all BCM2.0 beneficiaries. (1b) To describe the frailty process in older people receiving the programme: a qualitative study using semi-structured individual interviews with a biographical dimension. (2) To explore the enrolment process: focus groups with occupational therapists, following a realist approach. (3) To assess effectiveness: a prospective cohort study with up to 12 months follow-up of all BCM2.0 beneficiaries. (4) To identify barriers and facilitators to implementation: multiple nested case study in five areas, using a realist approach. (5) To build a learning community to clarify ethical considerations: communities of practice meetings.

Eligibility Criteria:
Inclusion Criteria:

* people aged 65 and over
* living at home in the Walloon and Brussels regions
* who are considered frail or at risk of frailty. The risk of frailty is defined as having at least one loss of intrinsic capacity measured by a trained occupational therapist using the ICOPE screening tool

Exclusion Criteria:

* People benefiting from other AViQ autonomy programmes of this project are excluded
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.


Eligibility Criteria:
Inclusion Criteria

- Patient must provide written informed consent

Exclusion Criteria

* Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403
* Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol
* Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot
* Any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment Refer to the original protocol for details of inclusion \& exclusion criteria. Any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol.

Other protocol-defined inclusion / exclusion criteria may apply.
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer.

OBJECTIVES:

* Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy.
* Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy.

A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.

Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.

Patients are followed annually for up to 20 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive unilateral breast cancer

  * T1-3, N0-1, M0 at presentation
* Complete macroscopic excision of tumor by breast conserving surgery or mastectomy
* No immediate breast reconstruction
* No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed
* Not enrolled on SECRAB or OSCAR trials
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

* Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor

Biologic therapy:

* Not specified

Chemotherapy:

* At least 2 weeks since prior cytotoxic agents
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)

Currently, the management of non-alcoholic fatty liver disease (NAFLD) patients has two main limitations. First, there is no approved treatment in NAFLD. Second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all NAFLD patients who represent 25% of the general population. Phase III trials have recently started in NAFLD with the hope of new treatments available in few years on the market. Consequently, we now need to develop and validate the non-invasive tools that will allow the identification of the subset of NAFLD patients who will benefit from treatment with the new drugs once they will be available in clinical practice.

We aim to generate of large multicenter cohort of biopsy-proven NAFLD patients including non-invasive tests of liver lesions (blood tests, elastography devices) and a biobank to promote a research network in the field of non-invasive diagnosis of liver lesions in NAFLD. Eight French centers highly experienced in this field of research will participate to the cohort.

Our primary aim will be to evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD. The primary endpoint will be advanced fibrosis as defined by fibrosis stages F3/4 by the NASH-CRN histological semi-quantitative scoring


Eligibility Criteria:
Inclusion Criteria:

* NAFLD diagnosis defined by the presence of at least two of the following elements:

  * Liver steatosis (hyperechoic liver on hepatic ultrasound, quantification \> 5.6 % by spectroscopy or MRI)
  * Presence of one metabolic risk factor:

    * BMI ≥ 25 kg/m2 or waist circumference ≥ 94 cm (male) / ≥ 80 cm (female)
    * Antihypertensive treatment or systolic BP ≥ 130 mmHg or diastolic BP ≥ 85 mmHg
    * Antidiabetic treatment or fasting blood glucose ≥ 5.6 mmol/l
    * Lipid-lowering treatment or triglycerides ≥ 1.71 mmol/l or HDL cholesterol \<1.1 mmol/l (male) / \<1.3 mmol/l (female)
    * Dysmetabolic hyperferritinemia
  * Anomaly in the liver enzyme test or liver function tests
* Indication for liver biopsy in the clinical management of the patient
* Obtaining the signature of the consent to participate in the study

Exclusion Criteria:

* Steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate)
* Excessive alcohol consumption in the last 5 years (\> 210 g / week for men or \> 140 g / week for women)
* Chronic infection with hepatitis B or C
* Any evidence of other concomitant chronic liver disease
* Decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome)
* Hepatocellular carcinoma
* Pregnant, breastfeeding or parturient women
* Persons deprived of their liberty by judicial or administrative decision
* Persons subject to legal protection measures
* Persons unable to consent
* Refusal to participate
Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy

The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.

Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.

Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients with solid tumors at an Advanced or metastasis stage requiring placement of implantable catheter for intravenous chemotherapy treatment
* Older than 18 years
* Express signed consent

Exclusion Criteria:

* Life expectancy less than 12 months assessed by investigator
* Infection or uncontrolled suspected infection
* Medical contraindication to port implantation by catheter in thoracic or humeral location
* Pregnant or lactating women
* Abnormal coagulation
* Immunosuppressed patients (for example known hepatitis B or C, or known positive Human Immunodeficiency Virus due to the spreading risk)
* Patient not affiliated to the French social security
* Access time to the humeral or thoracic port placement higher than 15 days (from the randomization theoretical date)
* Protected Adult or adult deprived of liberty
Microlearning Application for Diabetes Prevention

The purpose of this study is to test the effectiveness of a mobile application diabetes prevention program delivered with microlearning and microcoaching.

Patients with prediabetes who are interested in joining a diabetes prevention program will be randomized to either the mobile application diabetes prevention program or the traditional diabetes prevention program, which is delivered as a mixed program of in-person and virtual sessions.

Study participants in the mobile application version will download the Health U app from the Apple application store. The user will complete the daily microlearning modules and the health coach interactions within the Health U application. The 12-month diabetes prevention program will follow the widely clinically-validated CDC Get Active to Prevent T2 curriculum.

For participants participating in the in-person version, they will complete the diabetes prevention program, which meets in-person and virtually approximately once every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years old
* high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4)

Exclusion Criteria:

* pregnant
* non-English speaker
* not comfortable using a mobile application
Biomechanical Changes After Trabeculectomy

Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy.

Prior to trabeculectomy corneal biomechanics are measured with the Ocular Response Analyzer (ORA, Reichert) and the Corvis st (Oculus). Both instruments work with an air-puff which deforms the cornea. Intraocular pressure is measured like in non-contact air-puff tonometry. The ORA also measures corneal hysteresis (CH) and the corneal resistance factor (CRF) which are qualitative measures of corneal biomechanics. The Corvis is a high-speed Scheimpflug-camera (4330 frames/sec) that records the quantitative movements of the cornea. At least 6 month after uncomplicated trabeculectomy the measurements are repeated.

Eligibility Criteria:
Inclusion Criteria:

* Glaucoma patients in need of further IOP-reduction despite maximally tolerated therapy and assigned for trabeculectomy. Minimum of 18 years.

Exclusion Criteria:

* Corneal pathologies.
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)

The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and their metabolites, in asymptomatic patients with Acute Intermittent Porphyria.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Weight between 45kg and 110kg, inclusive, if male
* Weight between 45kg and 100 kg, inclusive, if female
* Diagnosis of acute intermittent porphyria (AIP)
* Elevated urine PBG level
* Not be pregnant or breast feeding, and must be willing to use a highly effective method of contraception

Exclusion Criteria:

* Clinically significant abnormal laboratory results
* Experienced an acute porphyria attack within past 12 months
* History of multiple drug allergies, intolerances or sensitivities
* History of recurrent pancreatitis
* Received an experimental drug, within 3 months of dosing
* Donated or lost an excessive amount of blood within 60 days of dosing