cyrilzakka/clinical-trials huggingface dataset:
Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability

This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary.

This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability using time and frequency-domains by ECG tracks. Will be assessed the blood pressure using the ambulatory blood pressure monitoring method of hypertensive elderly patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal repetition, an the ontrol group will remain sedentary.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensives
* Age 60 to 80 years
* Nonactive

Exclusion Criteria:

* Orthopedic problems or other problem that prevented the exercises
* Change in drug treatment during protocol
* Absence in more than 25% of the exercise sessions
Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients

Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU.

This is a double-blinded, randomised clinical trial.

Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU.

This is a double-blinded, randomised clinical trial. After conventional therapy consisting of debridement, infection control and offloading, patients were randomly allocated to receive either a piscean matrix dressing (the study group) or a saline-moistened gauze dressing (control group) for wound care. The reduction in DFU size and the number of patients with complete healing were measured throughout the treatment and in follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patients with neuropathic DFUs at Grades I or II for a period of at least 12 weeks, based on the Wagner classification;
* be able to understand simple instructions and provided voluntary, signed informed consent.

Exclusion Criteria:

* active infection which might lead to hospitalisation, gangrene,
* systemic inflammatory or autoimmune disease
* renal failure
* presence of ischaemia or osteomyelitis
Impact of Flaxseed on the Syndrome Metabolic Inflammation

This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and inflammatory indicators in male workers of a food industry.


Eligibility Criteria:
Inclusion Criteria:

* Work in the manufacturing company in the city of Itu-SP.
* Have at least three of the following cardiovascular risk factors: waist circumference ≥ 90 cm; overweight or obese characterized by BMI ≥ 25 kg/m²; fasting total cholesterol ≥ 200 mg/dL, LDL- cholesterol ≥ 130 mg/dL and HDL-cholesterol \< 40 mg/dL, triglycerides ≥ 150 mg/dL; glycemia ≥100 mg/dL; and hypertension characterized by systolic blood pressure ≥140 mm/Hg and/or diastolic blood pressure ≥ 90 mm/Hg.

Exclusion Criteria:

- Female gender
Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment

The purpose of the study is to improve the understanding of key patient reported outcomes such as quality of life as well as clinical outcomes in hemophilia A, in a global real world setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 or over.
* Have documentation of physician-confirmed diagnosis of moderate or severe Hemophilia A (severity defined as moderate = FVIII activity 1% to 5% and severe = FVIII activity ≤1%).
* Signed written informed consent provided by the patient or the patient's parents for patients under the age of 18 (dependent of local regulations).
* Signed written assent is also required for patients under the age 18 years (dependent on local regulations).
* Plan to receive at least half of their Hemophilia care at the registry site.
* Willing and able to enter data as per the data collection schedule.
* Currently receiving prophylactic or on demand treatment (including within last 6months for on demand).
* Expected life expectancy of at least 2 years.

Exclusion Criteria:

* Patients with Hemophilia B
* Patients with von Willebrand disease (vWD)
* Patients with other rare bleeding disorders
* Unable to comply with the study protocol
Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement

The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.


Eligibility Criteria:
Inclusion Criteria:

* (i) age \> 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ Ⅱ; (iv) failed GDMT; (v) Euro-SCORE \> 4.

Exclusion Criteria:

* (i) left ventricular ejection fraction \< 40%; (ii) systolic pulmonary arterial pressure \> 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.
Cervical Video Assisted Thoracoscopic Surgery (C-VATS)

Although thoracic NOTES may not be ready for human trials, a new minimally invasive technique to access the pleural cavity and perform pleural, pulmonary and mediastinal procedures would be possible. Cervical Video Assisted Thoracoscopic Surgery (C-VATS) is a technique that borrows from traditional VATS procedures, from cervical mediastinoscopy, and from flexible endoscopy. All of these procedures are very familiar to the thoracic surgeon.

The current feasibility and safety study examines C-VATS as a method of evaluating, biopsying and performing pleurodesis in patients with pleural disease and or effusion.

Hypothesis: C-VATS is a feasible and safe method of entering the pleural space in order to perform pleural evaluation, pleural biopsy and pleurodesis in patients with pleural disease and/or pleural effusions.

Objectives: Evaluate the safety and feasibility of C-VATS in patients with pleural disease.

Design: Prospective, cohort, feasibility and safety study.

Methods: Patients referred to all thoracic surgeons in the Division of Thoracic Surgery at the CHUM Notre Dame campus for the diagnosis or treatment of pleural based diseases will be screened for enrolment. The investigators plan to recruit 10 patients in this initial study. Eligible patients will be consented by one of the thoracic surgeons at the CHUM.

All procedures will be performing in the operating room at the CHUM Notre Dame Hospital. All patients will be admitted prior to their procedure and treated on the post-operative thoracic surgery ward using standard post-VATS procedural treatments. All cause, as well as procedure specific morbidity will be recorded by the study investigators on the day of the procedure, every day in hospital until discharge and at 1 week, 4 weeks and 12 weeks post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be those that would be candidates for the same pleural procedure (biopsy, drainage and pleurodesis) using a VATS technique

Exclusion Criteria:

* Anticoagulation including Warfarin, Heparin or Clopidogrel which cannot be stopped
* Patients less than 18 years old
* Pregnant patients
* Patient unable to extend neck fully
* Patients with cervical spine instability
* Patients having had previous neck or mediastinal surgery which would preclude mediastinoscopy
* Patients having previously undergone mediastinal irradiation
* Patients having been previously diagnosed with mediastinitis
* Active cervical cutaneous or deep cervical infections
Multidisciplinary Ambulatory Intervention Program in Family of Children and Adolescents With Obesity

Obesity has become a pandemic, and it is today's principal neglected public health problem.

Obesity has increased dramatically during the past two decades At adolescence, it is an aggravating issue, because obesity tends to persist in adulthood and the longer its duration, the higher the associated mortality and morbidity. Obesity imposes a heavy health and social burden, and it is widely recognized that treatment is costly. If obesity is not successfully addressed by late adolescence, the likelihood of weight loss in adulthood is as low as 5%. Therefore, prevention is crucial, and children and adolescents should be a priority target.

Treatment of obesity is costly, time consuming, difficult and the results aren't always satisfying On most cases the patients receive dietary advice only (6-10 visits per year). And usually the patients end the treatment early due to lack of results.

The best treatment of children and adolescent obesity is done in highly specialized settings, by a multidisciplinary team. Those programs have a limited number of locations (not always in proximity to the patients' residence), in addition, they are long term treatments and therefore are hard to complete successfully without additional support, Therefore only a limited number of patients can benefit from such programs.

Due to the reasons mentioned above, many families tend not to start the process of treating their obese child, or turn to commercial weight loss programs, or put their children according to their beliefs and diets.

Therefore ambulatory medicine is the ideal setting for the treatment of children and adolescent's obesity, it's also in proximity to the patients' residence, the medical team has a deep knowing of their patients and the possibility for long term maintenance and follow-up.

We propose a trial of obesity treatment by behavior modification program, including parents as agents of change.


Eligibility Criteria:
Inclusion Criteria:Children (6-18 years) with BMI in the 85th to 95th percentile or higher

Exclusion Criteria:Children with chronic diseases treated with chronic medications.

Refuse to participate in to the study
Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.

Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.

This study is a prospective, randomized and controlled trial. In this study aim, the effect of kangaroo care and swaddling methods applied during heel blood collection on the pain levels and crying times in newborns will be examined.

Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; kangaroo care group (n=40), swaddling group (n=40), and control group (n=40).

Data were collected using the Infant-family Information Form, NIPS - Neonatal Infant Pain Scale, and Crying Follow-up Form.

Eligibility Criteria:
Inclusion Criteria:

* Parents who volunteered and gave consent to participate in the research
* Full term neonates (38-42 weeks of gestation)
* Underwent heel stick blood drawing for routine metabolic screening,
* Aged 1 to 4 days
* Passed the hearing screening
* Birth weight between 2500-4400 grams
* Parents who know how to read, write and speak Turkish.

Exclusion Criteria:

* Parents with any mental problems
* Infants with any chronic disease and congenital anomalies.
Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men

The purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).


Eligibility Criteria:
Inclusion Criteria:

* Age range: 21 years and older
* Body mass index between 25.0-39.9 kg/m2
* Weight stable (\< 4.5 kg (\~10 lbs) weight gain or loss within last 6 months)
* Body fat \>25% (assessed by skinfold and plethysmography (if needed))
* Non-smoking (within the last 6 months)
* Constant habitual activity patterns (within last 3 months)
* Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose \<110 mg/dl)
* Not taking medications known to influence appetite or metabolism
* Non-diabetic

Exclusion Criteria:

* Age: \<21 years
* Body mass index: outside of the 25.0-39.9 kg/m2 range
* Gained or lost \> 4.5 kg (10 lbs) within the last 6 months
* Body fat \<25% as assessed by plethysmography
* Smoker (currently or within the last 6 months)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Clinically diagnosed as diabetic
* Allergies to eggs
* Lactose intolerance
* Clinically diagnosed with diverticulosis
* Clinically diagnosed with diverticulitis
EUS-guided RFA for Solid Abdominal Neoplasms

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic cancers.

The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal neoplasms.

RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumours and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.

The current study would be a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from solid neoplasms of the liver, stomach and adrenals would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 \& 3 year overall and disease-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years-old or above
* Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (\<5cm in largest diameter) that is indicated for treatment.
* Unsuitable for surgery, due to one (or more) of the following items:

  * ASA score \> II\*
  * An alternative advanced malignancy
  * Unsuitable for surgery upon expert's opinion for any other reason
* Healthy individuals who are not keen for surgical resection
* Eligible for endoscopic intervention
* Written informed consent

Exclusion Criteria:

* Coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL
* Pregnancy
* Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
* Patients unwilling to undergo follow-up assessments
* Patients with liver cirrhosis, portal hypertension and/or gastric varices.
Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.


Eligibility Criteria:
Inclusion Criteria:

1. cis-gender females at least 18 years of age
2. HIV-seropositive and a patient of the recruiting clinic
3. English speaking

Exclusion Criteria:

1. severe mental illness
2. not being willing able to provide informed consent
3. not willing or able to attend study visits
A Randomized Controlled Trial of Ambient Artificial Intelligence Scribe Technologies

This is a three-arm pragmatic RCT of 238 outpatient physicians at a large academic health system, randomized 1:1:1 to one of two AI scribe tools or a usual-care control group. The two-month study will observe and compare the effects of each tool prior to system-wide roll out of selected tool (anticipated Spring 2025). We will use covariate-constrained randomization to balance the arms in terms of physician baseline time in notes, survey-measured level of burnout, and clinic days per week.

The primary purpose of the initiative is to improve quality, efficiency, and business operations at University of California, Los Angeles (UCLA) Health, and this initiative is not being done for research purposes. The results of this operational initiative will inform the widespread roll out of AI scribe tools across all providers within the UCLA Health System. Nevertheless, the UCLA study team plans to rigorously examine and publish the impact of this intervention across the health system, which is why the study team pre-registered the initiative.

This study will assess operational-oriented outcomes across all groups. Notably, all groups will eventually receive all interventions over time in this observational study of a randomized roll out of a QI initiative. Moreover, the primary purpose of this initiative is operational. In other words, based on the results of this initiative, one of these tools will be eventually selected and operationalized widely across the health system.

Enrolled participants are randomized to one of three groups. Randomization was needed to overcome secular trends, seasonal and holiday effects in December, and other factors confounding the relationship between exposure to the AI tools and the outcomes.

The primary aim of this study is to evaluate the impact of two ambient AI scribe technologies on clinician change from baseline time spent on EHR documentation, comparing each scribe to a control group. Secondary objectives include assessing the AI scribes' impact on clinician metrics such as burnout, physician satisfaction, and productivity. Additionally, the study team intends to perform an economic evaluation analysis of the tools to guide business decision making. The study team will also analyze physician reported effects of the AI tools on patient safety, equity, and any unintended consequences of the initiative.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory care physicians within the UCLA Health system who held at least one half-day of clinic per week

Exclusion Criteria:

* Trainee providers (e.g., residents, medical students) and allied healthcare professionals (e.g., RNs, PAs)
* Attendings who work exclusively with trainees
Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)

This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and second, to explore neurobiological mechanisms of action of guanfacine.

Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time.

Eligibility Criteria:
* Males and females, age 18-65
* Diagnosis of PTSD from combat or civilian trauma
* No major medical problems such as diabetes, cardiovascular disease
* Taking no psychiatric medication, or taking only one SSRI antidepressant