cyrilzakka/clinical-trials huggingface dataset:
A Chronic Disease Self Care Management Pilot Study

The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation and self-care management of their chronic disease.

The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation, and self-care management of their chronic disease. The participants will include people 18 years and older that have been diagnosed with a chronic disease. This pilot study will use a pre-post design. Data will be collected initially and then at the seventh session. The intervention will be provided in seven sessions face-to-face for the first three sessions and then via video conferencing for the last four sessions. Each session is facilitated by three researchers. Once the sessions are finished the participants will be invited to a focus session so that qualitative data can be collected in week nine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

  * Undergoing treatment for chronic illness
  * Cognitive capacity to participate in group formats
  * Able to answer questions from questionnaires
  * Able to read and speak English.
  * Score greater than 18 on the MoCA cognitive test

Exclusion Criteria:

* Major reduction in cognitive capacity (i.e. major strokes, dementia, or other related conditions).
* Serious mental illness that impacts the ability to give consent or limits effective participation within a group discussion as assessed by the PI and RA in consultation following routine study protocols used in the study setting (patients may suffer from mild cognitive impairment but must be able to understand and complete questionnaires and engage in intervention groups).
* Patients in palliative phases of cancer.
* Patients in an acute medical crisis or in need of intensive care. -Patients who attend similar interventions in the same period or within the past 3 months. -
Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Stroke Risk Factors and Neurological Function in Stroke Patients

Introduction and Purpose:

Patients with stroke have over a decade of experience with vascular laser treatment. Previous studies predominantly used low-energy vascular lasers with red light, specifically helium-neon lasers with a wavelength of 632.8nm. However, different colored lights are absorbed by cells in the body in varying proportions, leading to potentially different effects. Therefore, there is an interest in understanding the impact of other colored lights on stroke patients. To understand the practical effects of low-energy laser treatment with different colored lights on improving neurological function and controlling recurrent stroke risk factors.

Methods:

A randomized crossover trial will be conducted with a study population consisting of individuals aged 20 and above who have experienced their first stroke within the last 6 months. Exclusion criteria include patients with skin conditions unsuitable for injection or light exposure, those with light allergies, pregnant individuals, those with abnormal blood clotting function, those with implanted pacemakers, and individuals unable to comply with the 5-month study plan. Participants will undergo 10 sessions of infrared light and 10 sessions of blue light vascular laser treatment. Blood tests and neurological assessments will be conducted before each treatment session (10 irradiations) and at the end of the two-month washout period between the two different colored lights. Descriptive analysis and pair t-tests will be employed to compare baseline values between the two groups. Subsequently, repeated measures ANOVA will be used to analyze differences between the intervention group and the control group. The study will examine whether various influencing factors are associated with receiving vascular laser treatment with different colored lights.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as a first-time stroke patient.
2. Onset of illness within 6 months of enrollment.
3. Recruitment period from January to December of the year 113.
4. All participants or their legal representatives must sign the informed consent form.

Exclusion Criteria:

1. Skin diseases that make injection or photosensitivity unsuitable.
2. Pregnancy and abnormal blood clotting function.
3. Presence of a cardiac pacemaker.
4. Inability to comply with the 5-month study plan.
Enhancing Tobacco Abstinence Following Hospitalization

The primary aim of this study is to examine the efficacy of a 12-week nurse-delivered relapse management intervention designed with conceptual underpinnings from Self-efficacy Theory to enhance smoking abstinence of hospitalized smokers following their hospital discharge. Specifically this study asks, does a 12-week Self-efficacy Theory driven relapse management intervention enhance smoking abstinence following hospitalization by increasing smoking abstinence point prevalence as measured by carbon monoxide validated self-reports of smoking, when compared to subjects receiving only enhanced usual care?

A randomized controlled two-group design with an intent-to-treat approach for handling protocol deviations will be used to examine the primary aim of this project. The sample will consist of 80 consenting smokers prospectively recruited during hospitalization. Subjects will be randomly assigned by equal allocation to an intervention group or an enhanced usual only group. A baseline adaptive randomization procedure will adjust the random equal ratio of treatment assignment to maintain sampling balance of the groups for race (White/Black/Other), gender (male/female), and three comorbid categories (only tobacco related illnesses/ tobacco related and unrelated to tobacco illnesses/ unrelated to tobacco illnesses). All subjects will receive enhanced usual care, which will consist of receiving a supportive message to quit smoking and smoking cessation materials. Subjects assigned to the intervention group will receive 9 intervention sessions with a nurse aimed to enhance their self-efficacy in self-management of tobacco abstinence. These sessions will occur over 12 weeks following hospital discharge. All but the initial session will occur by telephone. Subjects will be asked to participate with follow-up activities 12 weeks and 24 weeks following their hospital discharge, which requires the measurement of exhaled carbon monoxide and the completion of questionnaires by self-administration and interview with study personnel. Subjects will exit from study following the 24-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* smoked one cigarette within 30 days of hospital admission
* admission to a medical/surgical patient care unit
* 18 years of age or older

Exclusion Criteria:

* diagnosis of cancer in a terminal state,
* under evaluation for organ transplantation or awaiting transplantation,
* cerebral vascular disorders,
* senile dementia,
* Alzheimer's disease,
* abstinence from smoking greater than one month,
* non-English speaking,
* lack of a home telephone,
* lack of a mailing address,
* lack of any ability to participate with self-care activities,
* and transfer to a rehabilitation hospital or nursing home following their hospital admission.
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion

A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.


Eligibility Criteria:
Inclusion Criteria:

* age: 35-70 years
* diabetes duration: \>5 years
* documented poor glycemic control (HbA1c =\>8% despite medical treatment according to GCP)
* presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
* availability to comply with the entire follow-up

Exclusion Criteria:

* general contraindications to BPD (applies also to medical controls)
* presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration \<0.5 mcg/L
* blindness
* severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
* heart failure
* recent history (less than 12 months) of myocardial infarction, stroke or TIA
* unstable angina
* pregnancy
* previous or concomitant malignancy
* severe active inflammatory, neurologic, or cardiovascular conditions
* geographic inaccessibility
* any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results
Addressing Colorectal Cancer in South Florida Firefighters

The standard way of screening for colorectal cancer is to have a series of fecal blood tests, where a sample is taken from a participant's stool, or an endoscopic procedure performed by a doctor, where a camera is used to look inside the bowel. This research study will use a test performed by the participant. This test will look for changes in the stool that can identify if participants are at higher risk for cancer.

Another aim of this study is to better understand what firefighters and retired firefighters think about colorectal cancer and other health issues. This information will help us develop programs that may improve colorectal cancer outcomes in the firefighter community.


Eligibility Criteria:
Inclusion Criteria:

* For this study, participation is open to active and retired firefighters:

  1. ≥ 40 and ≤ 65 years of age,
  2. who work or worked in Florida Fire and Rescue departments and
  3. report never having fecal occult blood test (FOBT) or sigmoidoscopy/colonoscopy in their life or only one FOBT in the past year, a sigmoidoscopy in the last 5 years or a colonoscopy in the last 10 years. The research assistant will assess eligibility using a brief screener that will be completed online via RedCAP.
* For years 2 and 3 of the study, the investigators will enroll previously eligible participants who did not complete colorectal cancer (CRC) screening during year 1. The investigators will also enroll participants who completed fecal immunochemical test (FIT) with our study during year 1 and 2. They will be contacted via RedCAP and a follow up phone call at the 1 year mark of their previous screening. Based on national guidelines, FIT screening is suggested on a yearly basis. The eligibility criteria will be the same and participants will sign a revised informed consent form, stating that they understand that they are being re-consented for the same study.
* Participants, ages 50-65 years old, meeting the above criteria who declined the offered standard-of-care FIT will then be offered the blood-based septin9 test 90 days from the initial offering. FDA guidelines require the participant to be at least 50 years old to participate in the septin9 blood collection. The blood based test will be collected by a nurse or certified phlebotomist in the community setting.

Exclusion Criteria:

* Individuals, who have a personal history of CRC, inflammatory bowel disease (ie, Crohn disease involving the colon or ulcerative colitis) will be excluded from participation as these conditions increase the likelihood of positive test results not associated with the onset or recurrence of CRC disease. Additionally, individuals will be excluded if they are not physically capable of performing the FIT themselves.
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.

IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* active mild to moderate UC
* no other chronic disorders

Exclusion Criteria:

* changed the type and dosage of their medication in the last month
* those who have relapses that required hospitalization and change the type and dosage of medications during the intervention
* patients who do not want to continue the study protocol
Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers

The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults with peripheral arterial disease.
* Arterial or arteriovenous ulcers on lower leg
* Age \<18

Exclusion Criteria:

* Adults with non-ischemic ulcers,
* Purely venous ulcers,
* Purely traumatic wounds,
* Wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, Buerger disease, radiation arteritis),
Efficacy of Bimatoprost 0.03% in Patients Who Are Low-Responders to Latanoprost

To evaluate the IOP-lowering efficacy of bimatoprost 0.03% in patients found to be low-responders to latanoprost therapy.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age

  * Documented low-responder to latanoprost therapy as delineated in the outline above.
  * Diagnosis of open-angle glaucoma or ocular hypertension
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to bimatoprost or any component of any study medication

  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension
  * Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted)
  * History of intraocular surgery within the last 3 months
Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure

The goal of this feasibility study is to evaluate the safety and efficacy of the Renal Stimulation (RNS) by Direct Wire Pacing, during Renal Denervation (RDN) procedure in patient candidate for renal denervation with the ParadiseTM System. The main questions it aims to answer are:

* Is the RNS before RDN a straightforward method, allowing quantification of the renal sympathetic traffic?
* Does the RNS increase blood pressure (SBP), and is this increase significantly blunted after RDN?
* Does the 3-month 24h SBP decrease correlated with the RNS-induced SBP change before RDN?
* Can the difference between RNS-induced SBP rise before and after RDN be used as a procedural endpoint for RDN? Participants will be asked for their agreement to conduct an RNS before and after the RDN. No additional experimental procedure will be added to the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patient willing and able to comply with the protocol and has provided written informed consent.
* Age ≥18
* Patient candidate for renal denervation with the ParadiseTM System based on physician's assessment.
* Patients affiliated to a social security system

Exclusion Criteria:

* Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:

  * Renal arteries diameter \< 3 mm and \> 8 mm
  * Patient with relevant renal artery disease (% diameter stenosis \> 30%, aneurysm or fibromuscular disease)
  * Stented renal artery
  * Iliac/femoral artery stenosis precluding insertion of the ParadiseTM catheter
  * Known allergy to contrast medium
* Patient with known secondary cause of hypertension
* Patient with contraindication to chronic anticoagulation therapy or heparin
* Patient with Type 1 diabetes mellitus
* Patient with more than one accessory renal artery
* Woman currently pregnant or breastfeeding
* Patient with other concomitant conditions that may adversely affect the patient or the study outcome
* Patient with mental or physical inability to participate in the study
* Patient under judicial protection, tutorship, or curatorship
Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects

This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of which approximately 600 subjects will be from sites in China. Subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.

After providing consent, subjects will enter a screening period of approximately 28 days to verify eligibility for the trial. Eligible subjects will be considered enrolled and progress to the Randomization visit. Results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. Randomized subjects will enter the 12-week treatment period, followed by a 40-week long-term treatment period and a 6 week follow-up, for a total of 58 weeks (approximately 14 months) study participation. Subjects will attend clinic visits as shown in the Schedule of Activities. Subjects will be randomized to receive either 150 mg Q2wks of bococizumab or placebo in a 1:1 ratio. Lipid levels will be blinded to the investigator and staff, subject and sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Males and females at the age or over 18 years of age.
* With primary hyperlipidemia or mixed dyslipidemia.
* Treated with stable daily dose of statins
* At high or very high risk of incurring a CV event
* Fasting LDL-C \>=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of statins; Fasting LDL C \>=77 mg/dL (1.99 mmol/L) for subjects not on highest approved dose.
* Fasting TG ≤400 mg/dL (4.51 mmol/L)

Exclusion Criteria:

* Prior exposure to bococizumab or other investigational PCSK9 inhibitor
* NYHA class IV, or Left Ventricular Ejection Fraction \<25%
* Poorly controlled hypertension
* History of hemorrhagic stroke or lacunar infarction resulting in a stroke
* Untreated hyperthyroidism or TSH \>1 × ULN
* Undergoing apheresis or have planned start of apheresis.
Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate

Hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. Despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. The average time for hormonal therapy to be effective is about 18 months. Chemotherapy combinations which can treat the disease when it no longer responds to hormonal therapy have been developed, but these treatments are not curative. One of these combinations is estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a decrease in their PSA (Prostate Specific Antigen) or shrinkage of tumors after treatment with this chemotherapy. Despite this, these men have all developed further disease progression requiring additional treatment. One possible way to make chemotherapy more effective is to give it when the number of tumor cells is smallest, and the number of cells to be killed is at a low level. One situation in which this is true is when a man has responded to hormonal therapy any tumors are at their smallest size. This study will test whether the addition of chemotherapy at that time will prolong the time until the cancer becomes unresponsive to hormonal therapy.


Eligibility Criteria:
All patients must have a histologic diagnosis of adenocarcinoma of the prostate with evidence of metastases on bone or CT scan. Patients with regional metastases to pelvic lymph nodes (D1 disease) as their only site of metastases will be excluded from this study.

Patients on androgen suppression therapy at the time of registration must have received less than seven months of therapy (excluding any neoadjuvant hormonal therapy) and must have a decreasing or stable PSA level.

Patients may not be undergoing concurrent chemotherapy, biologic therapy, or radiation therapy. Prior to radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior cytotoxic chemotherapy.

Patients may not have evidence of brain metastases or untreated spinal cord compression.