cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care

The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN Euskadi program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza-Basque Health Service) in which such intervention is implemented, compared to usual care control centers.

Objective: To evaluate the feasibility and effectiveness of the DE-PLANЄ program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza) in which such intervention is implemented, compared to usual care control centers.

DESIGN AND METHODS: A phase IV cluster randomized prospective clinical trial, conducted in 14 primary care centers from Osakidetza, which will be randomly assigned to intervention or control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years without diabetes but with high risk of developing it (FINDRISC scale\> 14), identified by a screening system. Nurses in intervention centers (GI) will implement DEPLANЄ for 12 months, a structured educational intervention on healthy lifestyles (diet and physical activity), while patients of the control centers will receive standard care for the prevention and treatment of type-II diabetes.

ANALYSIS: The feasibility will be reported as the reach, adoption and implementation of the program. The attributable effectiveness of the program will be determined by comparing the changes in the incidence and risk of developing diabetes in healthy habits quality of life, observed in patients exposed to DE-PLANЄ intervention and of patients from control centers. The incremental cost-utility of DE-PLANЄ program will be also analysed.

Eligibility Criteria:
Inclusion Criteria:

* 45 to 70 years old
* high risk of developing type-II diabetes (Findrisc scale \> 14 points)

Exclusion Criteria:

* Disorders of the cardiovascular system
* Transplant recipients
* Renal or hepatic failure
* Severe chronic obstructive pulmonary disease
* Severe mental disorders
* Chronic and acute severe infections
* Metabolic uncontrolled disorders
* Restrictive pathology of muscles, bones and joints
* Complicated pregnancy
* Contact difficulties
Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus

One of the best understood mechanisms by which cytokines activate signals, thus eliciting specific responses in target cells, involves enzymes such as Janus kinases (JAKs) and transcriptional factors such as signal transducers and activators of transcription (STATs). For immune mediated diseases, both activating and inactivating mutations of JAKs and STATs may cause abnormalities in immune homeostasis. Polymorphisms of JAK/STAT genes have been linked to susceptibility for rheumatoid arthritis (RA) , systemic lupus erythematosus (SLE), psoriatic arthritis (PA) and inflammatory bowel disease (IBD) .

Janus_kinase 3 expression will be evaluated in the serum and renal tissue of lupus patients during active stage of the disease through this study

Investigators will assess the relationship between the expression of Janus_kinase 3 and the clinical and laboratory parameters of disease activity . Disease activity will be assessed through the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Also, investigators will evaluate the relationship between Janus_ kinase 3 expression and histopathological classes of lupus nephritis according to the 2003 International Society of Nephrology/ Renal Pathology Society (ISN/RPS) classification of lupus nephritis. This will be done through Janus_kinase 3 assessment in the blood and renal tissue of lupus patients.

Eligibility Criteria:
Inclusion Criteria:

* Age younger than 16 years.

  * Active disease stage
  * Patients with biopsy proven lupus nephritis according to ISN/RPS classification criteria of lupus nephritis

Exclusion Criteria:

* Lupus patients in remission.

  * Lupus patients with end stage renal disease.
  * Lupus patients with secondary thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS).
  * patients with moderate or severe infection
Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testictular Cancer

This study aims to evaluate how retroperitoneal lymph node dissection (RPLND), a surgical treatment for testicular cancer, may affect urinary and sexual functions in men. RPLND involves the removal of lymph nodes from the abdominal area and is sometimes necessary in patients who are not eligible for chemotherapy or who have residual disease after chemotherapy. While this surgery is known to carry a risk of affecting ejaculation, its potential impact on other areas such as urination or erection is not well understood.

The study will prospectively follow adult men undergoing RPLND. It will assess changes in lower urinary tract symptoms, urine flow, ejaculation, erection, and overall quality of life before surgery and during follow-up visits up to 6 months after the operation. Patients will complete standardized questionnaires and undergo simple, non-invasive tests such as urine flow measurement.

By identifying how RPLND may influence urinary and sexual health, this study seeks to improve understanding of the full range of effects of this treatment. The findings may help clinicians better inform patients before surgery and support improved post-operative care.

This is a prospective observational study designed to evaluate the impact of retroperitoneal lymph node dissection (RPLND) on lower urinary tract and sexual function in patients treated for testicular cancer. The study incorporates validated patient-reported outcome measures (PROMs) alongside objective functional assessments to characterize post-RPLND urinary and sexual sequelae over time.

Patients will complete standardized questionnaires preoperatively and at scheduled postoperative intervals, including the International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), International Index of Erectile Function (IIEF-5), Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD), and EQ-5D-5L for health-related quality of life. Objective evaluation will include uroflowmetry and ultrasound-based measurement of post-void residual volume.

Eligibility Criteria:
Inclusion Criteria:

* Adult male with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)

Exclusion Criteria:

* History of RPLND
* Lack of consent
Efficacy Trial of Raices Nuevas

This trial will test the impact of a culturally tailored and theory driven primary intimate partner violence prevention intervention with Spanish speaking Latino men.

In this randomized controlled trial, Spanish speaking Latino men will be recruited from community church settings in Southwest Detroit and randomly assigned to: (a) an intimate partner violence prevention intervention or (b) a wait-list control condition. Latino men assigned to the intervention will receive, in a small group setting, an 8-session, primary intimate partner violence prevention intervention based on the Duluth model and culturally and linguistically tailored for Spanish speaking Latino men. Measures will be administered at pre-test, and at three and six months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Spanish speaking Latino men
* between the ages of 18 and 55
* in a stable relationship for at least the past three months

Exclusion Criteria:

* severely mentally impaired
* hearing impaired
SSRI and Buprenorphine

This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.

Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.

Eligibility Criteria:
Inclusion Criteria:

* opiate dependence
* Ham-D \> 14

Exclusion Criteria:

* no psychiatric contraindications to using escitalopram
* no medical contraindications to using escitalopram
* methadone dose \< 30
* no current SSRI use
Remote Ischaemic Preconditioning Combined With Exercise Training on Vascular Function.

Remote Ischaemic preconditioning' (RIPC) is defined as short controlled sequences of repeated inflation of a blood pressure cuff on the upper arm (to reduce blood flow) for 5 mins followed by recovery (cuff deflation so blood flows normally again). An intervention consisting of 4 cycles of 5 min of arm cuff inflation followed by deflation performed 3 times per week, spread over 8 weeks has been shown to improve blood vessel function in young individuals without any medical conditions. This is a simple and easily applicable intervention that could help the blood vessels capacity to deliver blood to an organ (e.g. heart or the muscle).It is currently unknown if RIPC combined with exercise training, provides stronger benefits to our blood vessels than RIPC alone. Therefore, the aim of this study is to investigate if combining RIPC with an 8 week exercise training programme improves blood vessel health more than 8 weeks of RIPC alone.

A bout of ischaemia using a blood pressure cuff on the upper arm inflated to a pressure of 220 mm Hg for 5 mins followed by reperfusion (deflation of the cuff) is commonly known as remote ischaemic preconditioning (RIPC). Traditionally, RIPC refers to 5 minutes of inflation-5 minutes deflation repeated 4 times. Recent research has investigated the impact of repeated RIPC interventions on cardiovascular health. One previous repeated RIPC intervention, whereby RIPC was performed 3 times per week for eight weeks, identified that RIPC significantly enhanced conduit artery endothelial function and microvascular function.

Exercise training is crucial for a healthy lifestyle, with the World Health Organization recommending that adults aged 18-64 should do at least 150 minutes of moderate aerobic physical activity per week, or at least 75 minutes of vigorous intensity activity. Interestingly, the impact of exercise training on the vasculature is similar to that of repeated RIPC interventions, with reductions in arterial blood pressure, increased in blood flow and improvements in systemic vascular endothelial function. No study has examined if combining exercise and RIPC provides enhanced effects on the vasculature compared to exercise alone.

The aim of this study is to investigate whether combining 8 weeks of exercise and RIPC is more beneficial to systemic vascular function that exercise alone.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent.
* Males and females 18 to 65 years.
* Body Mass Index \>30g/m2 or waist circumference of ≥94cm (male), ≥80cm (female).
* Raised blood pressure systolic \>130 or diastolic \>85 mmHg or normal
* Diagnosed with high cholesterol by GP or normal

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Previous myocardial infarction, stroke (including TIA) or thrombosis
* Diagnosed with Congestive Heart failure
* Unable to enroll for the duration of the study
* Pregnancy or lactation period
* Smoking
* Any arm injury that will prevent application of the RIPC-intervention
Feasibility of a Culturally-Specific Video Text Cessation Intervention With AA Quitline Callers

Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.

The main objective of this study is to assess the feasibility of delivering an mHealth tobacco intervention among state quitline enrollees. This will be measured through the assessment of interest and willingness to use the video text program, and the ability to receive video text messages (i.e., has technology capable of receiving and viewing video texts. At the end of the intervention, the team will assess satisfaction and perceived helpfulness of the video-text messaging program as an indication of acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as African American
* Enrolled in state quitlines within the past 3 months
* Have access to SMS texting

Exclusion Criteria:

* Does not meet inclusion criteria
Yoga for Treating People at Risk for Diabetes or With Both HIV and Depression

The purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. This study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both HIV and depression.

In recent years, western health practitioners have become increasingly aware of the potential health benefits of yoga. This study will comprise two substudies that will evaluate the effects of yoga in two distinct populations.

Participants in the first study will be people who are at risk for developing diabetes; participants in the second study will be people with both HIV and depression. All participants will practice yoga 3 to 6 days per week for 3 months. Blood collection will be done and weight and blood pressure measurements will be taken in study 1 participants; questionnaires will be used to measure depression and stress in study 2 participants. All study participants will be assessed at entry and at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria for Study 1 Participants:

* Meet certain laboratory requirements

Inclusion Criteria for Study 2 Participants:

* HIV infected
* Able to walk at least 50% of the time

Inclusion Criteria for All Participants:

* Written informed consent of parent/guardian, if applicable

Exclusion Criteria for Study 2 Participants:

* Require antiretroviral therapy
A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy

This is a dose finding study of a novel radiopharmaceutical agent, 153Sm-DOTMP. It will be studied alone and then in combination with external beam radiotherapy. The study design includes six cohorts, Levels 1-6. The first three cohorts of participants will receive 153Sm-DOTMP alone, and if this is determined to be safe, subsequent cohorts will receive the radiopharmaceutical followed by external beam radiotherapy.

This is a dose escalation study of a new radiopharmaceutical agent, 153Sm-DOTMP. Eligible participants will have osteosarcoma metastatic to bone, other solid tumors with bone metastases, or an unresectable localized osteosarcoma. Because of anticipated prolonged myelosuppression, participants will have a peripheral blood stem cell harvest. They will then be treated with 2 doses of 153Sm-DOTMP given 7 days apart. Twenty-four days after the initial dose, stem cells will be reinfused if needed. The first three cohorts of participants will receive only radiopharmaceutical. If Dose Level 3 is not the maximally tolerated dose (MTD), subsequent dose levels will include external beam radiotherapy, administered beginning on Day 15. The dose of external beam radiotherapy will be determined by dosimetry studies performed after each administration of study agent, and will be targeted to a tumoricidal dose of radiation. All participants will have disease re-evaluation 30 days following completion of all study treatments, and then at 4, 6, 8, and 12 months, unless they experience disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of osteosarcoma with either an unresectable primary tumor or metastases (including tumors with an intralesional resection).
* Measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan.
* Adequate renal function, defined as a measured creatinine clearance \>70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).
* Adequate hematologic function, defined as a platelet count \> 50,000 cells/mm3 and an absolute neutrophil count (ANC) \> 500 cells/mm3
* Life expectancy of at least 8 weeks.
* Karnofsky performance status \> 50%
* Subject must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or better.
* Patients must have previously received effective treatment for their underlying disease and have no potentially curative options available.

Exclusion Criteria:

* Subject has received prior radiotherapy to all known areas of current active disease or has a known contraindication to receiving radiotherapy.
* Subject is pregnant or breastfeeding.
* Patient is sexually active and does not agree to use accepted, effective forms of contraception.
SaliPen Human Factors Study for OTC Labeling

This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information For User (IFU)?

More specifically, this is a non-comparative case series study and is subdivided into two major parts. Those parts are:

1. Phase I: aimed at testing if, based on the IFU, the potential subjects can decide whether the study product is or is not appropriate to treat their condition and,
2. Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.

Phase I To simulate an OTC setting, potential subjects will be requested to read the label text on the outside of the study product package (external labeling) and determine whether the study product addresses their needs, without a provider direction or assistance.

Phase II The study product will be dispensed only to those subjects who will indicate that they voluntarize to participate in this phase of the study.

At Phase II subjects with xerostomia and that are willing to try the study product, will be requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects will use the study product in a supervised clinical setting. Subjects who report any discomfort will be offered the option to pause and remove the device upon such a request.

Correct use verification will be performed by the study investigators. Subjects will answer questions regarding product use, clarity of the IFU, ease of use, etc. Subjects will also receive an exam of their oral cavity.

Eligibility Criteria:
Inclusion Criteria:

For Phase I: 8 subjects with xerostomia and 8 without that are 18 years old or older For Phase II: Subjects with xerostomia that are 18 years old or older

Exclusion Criteria:

For Phase I:

* Children and adolescents (persons under 18 years of age)
* Persons with experience in the use of SaliPen

For Phase II: Subjects for them the study product is not indicated and/or do not agree to participate in Phase II. For the avoidance of doubt, the following conditions are exclusion criteria:

* Persons with experience in the use of SaliPen
* Children and adolescents (persons under 18 years of age)
* Epileptic disorder
* Persons that are allergic to the surface materials of the device

  * Electrodes: coated with gold
  * Body: made of methyl vinyl silicone rubber
* Use of a pacemaker
* Pregnancy
* Psychiatric or psychological disorders
* Involuntary muscle movement disorder (such as Parkinson's)
* Neurologic disorder in head and neck area
Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial Fibrillation

To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.

Participants will undergo AF ablation according to standard, contemporary techniques. The procedure will be performed under general anesthesia. As part of routine standard of care in patients with early-onset AF or patients who have PVCs, we will also test for inducibility of VT using a standardized pacing protocol. The research protocol will include LV mapping and identification of low voltage substrate using electroanatomical mapping as described below.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 and older
2. Diagnosed with AF before age 60
3. Scheduled for catheter-based AF ablation (de-novo or repeat)
4. Able to provide written, informed consent
5. P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control.

Exclusion Criteria:

1. Diagnosed with a genetic CM or arrhythmia syndrome prior to AF
2. VUS in 'possibly pathogenic' subgroup (control group only)
3. Pacemaker or ICD
4. Previous PVC or VT ablation
5. LVEF \<20%
6. Prosthetic mitral or aortic valve
7. Contraindication to heparin
8. Prior myocardial infarction.