cyrilzakka/clinical-trials huggingface dataset:
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of an eight-week text-based scheduled gradual reduction (SGR) intervention (a personalized eight-week reduction schedule paired with National Cancer Institute's \[NCI's\] Smokefree.TXT) compared to a control intervention (NCI Clearing the Air Cessation Booklet) on biochemically-validated smoking cessation six-month post-quit date in rural cancer survivors.

SECONDARY OBJECTIVE:

I. Compare the efficacy of the eight-week text-based SGR intervention and a control intervention on Linear Analog Self-Assessment (LASA)-6 overall quality of life (QOL) at 30-days post-quit date and six-months post-quit date.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in schedule gradual reduction program over 8 weeks to reduce the frequency of cigarette use. Patients also receive cessation support messages via text messages for 12 weeks.

GROUP II: Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.

After completion of study, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment
* Not currently on hospice
* Currently smokes \>= 5 cigarettes daily
* Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code \[RUCC\] code of 4-9)
* Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial
* Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program
* Patient has a cell phone or smart phone device with texting ability
* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
* Age \>= 18 years
* Participant must be willing to provide a urine sample.

Exclusion Criteria:

* Psychiatric illness which would prevent the patient from giving informed consent
* Patients with impaired decision-making capacity are not eligible for this study.
Trends in Intellectual Development in Down Syndrome

Previous foreign studies revealed that the IQ in Down syndrome (DS) declines with age, but not any investigation of domestic data in Taiwan was available. Individuals with DS are characterized by limited verbal development, and in this article, authors look into the diverging verbal-nonverbal abilities in the DS phenotype.

The present study investigated this by analysis the test results of development /intelligence scales. To compare initial cross-sectional data with longitudinal follow-up, about 12 people with DS were included.

Eligibility Criteria:
Inclusion Criteria:

* Down syndrome with psychological test results

Exclusion Criteria:

* Comorbidity of severe Autism or visual/auditory impairment
Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults

This is a placebo-controlled, crossover study investigating the pharmacokinetic bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo metabolites in a cohort of healthy, older adults.


Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women
* BMI 18.5-29.9 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Use of any stomach acid-lowering medications
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 95 mm Hg
* Regular use of oral steroids
* Regular daily intake of 2 or more alcoholic drinks
* Illicit drug use
* No fish oil supplements (including cod liver oil) for one month prior to study admission
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).

The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus).

The CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications.

The CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older.

Exclusion Criteria:

* All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old
Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy

The purpose of this study is to determine the maximum dose that is safely tolerated of the experimental drug Rhenium Re 188 P2045. This will be done by first treating patients at relatively low doses of Rhenium Re 188 P2045, observing them closely to assure that there are no bad side effects, then increasing the dose when we are confident that it is safe to do so.

We want to learn more about the side effect profile of both Technetium Tc 99m P2045 and Rhenium Re 188 P2045 and will do that by observing you closely after you receive the drug and by conducting multiple tests, as well as by asking you how you feel. We want to also learn if there is any benefit, in terms of lung cancer tumor reduction, as a result of treatment with Rhenium Re 188 P2045. This study has previously been posted by Berlex, Inc. Andarix Pharmaceuticals is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytologically documented Non-Small-Cell Lung Cancer (NSCLC) or Small-Cell Lung Cancer (SCLC) and has advanced or recurrent IIIb or IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell, mixed or not otherwise specified) or disseminated or recurrent SCLC or any lung cancer which has local recurrence.
* Has documentation of progressive disease following prior chemotherapy or who refused to receive standard chemotherapy.
* Has measurable tumor (at least 1 cm unidimensionally) in a previously non-irradiated area or, if in previously irradiated area, a substantial increase in size of tumor, based on CT scan within 8 weeks prior to enrollment; tumor in previously irradiated area only if it has increased by 50% or more from previous minimal diameter AND it is more than 8 weeks from the radiation.
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study

To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Undergoing IBD surgery using MIS (minimally invasive surgery) techniques
* Histological/radiological evidence of inflammatory bowel disease

Exclusion Criteria:

* Planned open surgical approach
* Lacks capacity to provide informed consent
Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis

The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin.


Eligibility Criteria:
Inclusion Criteria:

* idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
* dilated left ventricle
* ejection fraction below 45%

Exclusion Criteria:

* diabetes mellitus
* kidney failure (GFR \< 30, creatinine below 2,5 mg/dl
EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.

The secondary objectives include:

* Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;
* Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;
* To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;
* To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;
* To assess safety and characterize protocol defined adverse events and adverse device effects.

Eligibility Criteria:
Inclusion Criteria:

1. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)
2. Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
3. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
4. Willing to voluntarily sign the informed consent form
5. Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.

Exclusion Criteria:

1. Skeletally immature (less than 21 years of age) at time of implantation
2. Has or had an overt infection at the time of implantation
3. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
4. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
5. Has or had documented substance abuse issues
6. Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
7. Currently incarcerated or has impending incarceration
8. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
Return of Actionable Variants Empirical Study

This is a genomic implementation project with ancillary studies to understand the impact on patients' health and well-being of returning genomic results to them and depositing those results in the medical record.

Study participant DNA samples will be sequenced for 109 genes of interest along with genotyping of select polymorphisms. Genetic tests will be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab (Baylor Human Genome Sequencing Laboratory). Selected results (pathogenic/likely pathogenic) will be returned to participants by a genetic counselor and deposited into the Electronic Health Record (EHR).

Eligibility Criteria:
Inclusion Criteria:

* Moderate to Severe Hypercholesterolemia, elevated triglycerides, or colon polyps
* Resident of southeast Minnesota area
* Able to provide informed consent
* Current participant in the Mayo Clinic Biobank (08-007049, Cerhan PI), the Vascular Disease Biorepository (08-008355, Kullo PI), or the Study of the Genetic Determinants of Peripheral Artery Disease (PAD) (06-002911, Kullo PI) with blood derived DNA available

Exclusion Criteria:

* Pregnant women will be allowed to enroll in the study. This is not an interventional study and there will be no risk to the mother or neonate. Other vulnerable study populations will be excluded.
Effect of Transfer Energy Capacitive Resistive Therapy on Shoulder Pain and Function in Shoulder Impingement Syndrome

This study investigates the efficacy of combining Transfer Energy Capacitive and Resistive (TECAR) therapy with standard strengthening exercises in treating Shoulder Impingement Syndrome (SIS). A double-blinded randomized controlled trial will compare outcomes between patients receiving only strengthening exercises and those receiving both TECAR therapy and exercises. Key outcomes include improvements in pain, muscle strength, joint position sense, and shoulder function. The study aims to determine if TECAR therapy enhances treatment benefits beyond those achieved with exercises alone.

Background: Shoulder Impingement Syndrome (SIS) is a prevalent musculoskeletal condition characterized by pain and functional impairment due to the compression of rotator cuff tendons beneath the coracoacromial arch. Despite the effectiveness of conservative treatments such as strengthening exercises, there is emerging interest in additional modalities, including Transfer Energy Capacitive and Resistive (TECAR) therapy. TECAR therapy utilizes high-frequency electromagnetic waves to provide deep thermal energy, potentially enhancing tissue repair and pain relief.

Objective: This study aims to evaluate the effectiveness of combining TECAR therapy with a standard strengthening exercise regimen compared to strengthening exercises alone in patients with SIS.

Methods: A double-blinded randomized controlled trial will be conducted with 30 participants diagnosed with Neer's Stage I SIS. Participants will be randomly assigned to either a control group receiving only strengthening exercises or an experimental group receiving both TECAR therapy and strengthening exercises. The study will assess pain, shoulder muscle strength, joint position sense, and shoulder function using a range of validated instruments including the Visual Analogue Scale (VAS), Hand-Held Dynamometer (HHD), Digital Inclinometer, and the Shoulder Pain and Disability Index (SPADI).

Eligibility Criteria:
Inclusion Criteria:

* Both gender age from 25-40 with a clinical diagnosis of Neer's stage II SIS and body mass index (18.5-29.9)

  * Shoulder pain for at least three months
  * Painful arc of movement during flexion or abduction
  * Positive Neer's or kennedy- hawkins test or empty can test
  * Pain on resisted external rotation, abduction

Exclusion Criteria:

* Symptoms of cervical radiculopathy.

  * Diagnosed inflammatory disorder.
  * Neurological disorder.
  * Widespread pain condition.
  * Evidence of complete rotator cuff tear (positive drop arm test).
  * Previous surgery to the affected shoulder.
  * Noncompliance patient.
  * Pacemaker.
Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes

The purpose of this study was to determine whether TH9507, a stabilized analogue of growth hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or postmenopausal or surgically sterilized female subjects, 50 years of age or older;
* Documented diagnosis of type 2 diabetes as defined by the American Diabetes Association;
* Diagnosis of type 2 diabetes for at least 3 months before screening;
* Subjects on stable diabetes treatment regimens (receiving oral hypoglycemics with or without insulin) for at least 2 months before screening;
* Screening and pre-randomization glycosylated hemoglobin (HbA1c) \<10.0%, according to central laboratory;
* Body mass index (BMI) between 25 and 38 kg/m2
* Subjects willing to perform specified home blood glucose monitoring and comply with all study protocol requirements;
* Signed informed consent.

Exclusion Criteria:

* Serum creatinine \>2 mg/dL;
* Fasting triglycerides \>1000 mg/dL;
* Albuminuria \>200 mg/24 hours;
* Positive mammography (if female) or prostate-specific antigen (PSA) or prostate examination for cancer (if male);
* Use of oral or parenteral glucocorticoids in the 30 days before screening;
* Use of any experimental or marketed growth hormone, growth hormone secretagogues, insulin-like growth factor-1 (IGF-1), or insulin-like growth factor binding protein-3 (IGFBP-3) during the previous 6 months;
* Subjects with two or more severe hypoglycemia episodes within the past 6 months, or any hospitalization or emergency room visit due to poor glycemic control within the past 6 months. Similarly, during the lead-in period, any subject with more than one severe hypoglycemic episode or any hospitalization or emergency room visit due to poor glycemic control will be excluded from randomization;
* History of or presence of active concomitant conditions or diseases (e.g., myocardial infarction, poorly controlled hypertension, thyroid disease, rheumatoid arthritis, seizure disorder, diabetic neuropathy, diabetic retinopathy \[except subjects with only microaneurysms on fundus examination\]) that would interfere with the protocol conduct and endpoint measurements;
* Subjects with a major surgical operation during the 30 days before screening;
* Subjects with known hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma;
* Current cancer or history of cancer, except non-melanomatous skin cancer;
* Subjects with active infection at any body site or a history of severe infection (requiring oral or parenteral treatment) during the 30 days before screening;
* Subjects with clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the medical monitor);
* Subjects with allergy to synthetic growth hormone products or their excipients;
* Subjects who had previously received growth hormones in any clinical trial;
* Participation in a trial of an experimental drug or device within 90 days before screening.
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Eligibility Criteria:
Inclusion Criteria:

* MRI showing unilateral supratentorial cerebral tumor
* surgical tx within 4 weeks of baseline MRI
* KPS 60% or higher
* moderate to high grade malignant glioma

Exclusion Criteria:

* prior cytoreductive surgery for moderate or high grade glioma
* prior CNS radiotherapy
* prior chemo for this glioma
* more than one focus of tumor or tumor crossing the midline per MRI
* life expectancy less than 12 months
* sensitivity to temozolomide, nitrosoureas, or Gliadel wafer
Improving Outcomes in Cleft Palate Surgery

This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.

This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair.

The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons.

The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.

Eligibility Criteria:
Inclusion Criteria:

Active surgeon performing cleft palate repair in the US or Canada.

Exclusion Criteria:

none
Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI

Inclusion criteria:

* Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
* Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

* Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
* Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
* Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
* Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included


Eligibility Criteria:
Inclusion Criteria:

* Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
* IRB-approved informed consent signed

Exclusion Criteria:

* Contraindication to MRI
* Contraindication to endorectal examination
* Contraindication to prostate biopsy
* History of allergy to gadolinium chelates