cyrilzakka/clinical-trials huggingface dataset:
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women

The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program.

This trial will enroll Black women with elevated cardiometabolic risk (e.g., overweight or obesity, pre- or established diabetes, and elevated or high blood pressure) in early-to-middle adulthood (n=36; age=30-64 years) with insufficient resistance training (RT) participation. This 4-month single group pilot trial evaluates the feasibility, acceptability, and potential effects of a novel, remotely-delivered resistance training (RT) intervention. All participants will engage in RT during this trial and the web-based platform is the primary modality through which the remote RT intervention is delivered. Assessments are conducted at baseline and follow-up (month 4). Aim 1 will examine the feasibility and acceptability of the remotely delivered RT program. Aim 2 will examine the potential effects on RT behaviors. Aim 3 will examine the potential effects on clinical and patient-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Black or African American
* Female
* Age 30-64 years
* Insufficient resistance training engagement (\<2 sessions/week in the past 6 months)

AND

* Self-reported or documented diagnosis of at least one of the following conditions: Overweight, obesity, prediabetes, type 2 diabetes, elevated blood pressure, hypertension, or taking medications for any of these conditions
* Has an internet- connected device (i.e., computer, smartphone) and is willing to use it for intervention delivery
* If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment
* Residing within a 50-mile radius of the University

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure \>160/100 mm Hg)
* Weighing ≥ 450 lbs (upper limit for body composition assessment)
* Conditions or limitations that affect physical activity participation and/or the ability to --perform assessments
* Has a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe
* Unwilling to obtain medical clearance (if indicated by prescreening)
* Women who are pregnant or trying to become pregnant in the next 6 months
* Planning to relocate out of the area in the next 6 months
* Participating in another exercise and/or randomized research project
* Unwilling or unable to do any of the following: give informed consent; read/understand English; perform resistance training in their home, record and upload virtual exercise assessment sessions, and other protocol specific requirements
Treatment of Temporomandibular Disorders

The aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be carefully selected.


Eligibility Criteria:
Inclusion Criteria:

* Pain in orofacial area for at least 3 months
* Diagnosed at group 1 of RDC/TMD (myofascial pain with or without mouth opening limit)

Exclusion Criteria:

* Drug use for treatment of pain
* Functional limitations that would harm diagnosis
Derivation and Validation of the Extended Care (Ex-Care) Model II

The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is:

•Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery?

Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death).

The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.

From four predictors collected preoperatively ( American Society of Anesthesiology Physical Status (ASA-PS) classification, age, extent of surgery and its nature - elective vs urgency/emergency), through a multilevel logistic regression, a post-surgical in-hospital mortality prediction model will be developed, the Ex-Care II model. Discrimination and calibration measures will be used to determine the accuracy of the model. In addition, each predictor will have their odds ratio calculated for the study outcome. Once this model is developed, it will have its external validity tested in a second sample, using the same accuracy metrics.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study

Exclusion Criteria:

* Diagnostic procedures, with sedation only or with local anesthesia
* Patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation
* In the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement
Protein Supplementation to Enhance Exercise Capacity in COPD

Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.

Pulmonary Rehabilitation (PR) is a six-week supervised group exercise and education class. PR is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbation. Exercise intolerance/limitation is one of the commonest issues with COPD patients and this may be compounded by reduced muscle mass and malnutrition. COPD patients lose body weight and skeletal muscle mass which leads to muscle weakness and dysfunction, thus impacting functional ability and quality of life. Muscle weakness is caused by a prolonged sedentary lifestyle and voluntary immobilization. Importantly, being under-weight is associated with an increased risk of mortality in COPD.

Nutritional supplementation have been used to overcome malnutrition in COPD patients. It has been shown that nutritional support integrated with exercise training can improve exercise activity, decreased the risk of mortality, and improve muscle strength in undernourished COPD patients. However, uptake of nutritional supplementation during pulmonary rehabilitation, where the potential benefit may be greatest, has been limited by the absence of rigorous evidence-based studies supporting use.

Investigators want to investigate the effect of a nutritional supplement during a PR program on exercise capacity in COPD patients. Investigators will collect demographic data, distribute questionnaires, measure exercise performance, and some additional measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed COPD (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio \<0.7)
2. \>10 smoking pack year history.
3. Enrolling on a pulmonary rehabilitation programme.
4. Age of 18 and above.

Exclusion Criteria:

1. Patients with any physical or mental health disorders preventing compliance with trial protocol.
2. Unable to communicate in English
3. Malabsorption syndrome
4. Unable to perform the Incremental Shuttle Walk Test
5. Patients already using other types of oral dietary supplement, under the care of a dietitian.
6. Galactosaemia (contraindication)
7. Known cow's milk protein allergy or lactose intolerance
8. BMI \>30kg/m2 without recent weight loss of \>5%
Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children

this study will aim to evaluate the effects of dexmedetomidine, dexamethasone and Ondansetron on the prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation surgery.

Postoperative nausea and vomiting (PONV) is one of the most common and unpleasant postoperative complications, which is a major concern in surgical patients. PONV affects about 20-40% of surgical patients, with certain high-risk patients experiencing rates of up to 80%.

It has a high incidence in children, especially for tonsillectomy and dental surgery. PONV could lead to several adverse consequences, including dehydration, electrolyte imbalance, and wound dehiscence. it has also been reported PONV is associated with delayed hospital discharge, unplanned hospital admission, and increased financial costs required for patient care.

Several anti-emetic drugs have been described for the prophylactic control of PONV. Dexamethasone is common practice in surgery, as part of a multimodal pain and antiemetic strategy.

Ondansetron is a selective 5-HT3 receptor antagonist that exhibits an anti-emetic action by antagonizing vomiting signals in the afferent pathway from the stomach or small intestine and solitary tract nucleus and is effective at preventing PONV, however, the high cost of this drug has prevented it from being widely used.

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which has been widely used in clinical practice and has been explored extensively in the pediatric population due to its beneficial effects on perioperative morbidities. In the past few years, many studies in paediatrics have been published showing that dexmedetomidine lowered postoperative pain scores and opioid consumption, decreased the incidence of emergence agitation (EA), and improved the quality of recovery in pediatric patients undergoing different surgical procedures. In addition, a small selection of studies reported that dexmedetomidine could lower the incidence of nausea or vomiting after surgery and during the use of patient-controlled analgesia (PCA) in paediatrics. However, the effect of dexmedetomidine on PONV remains poorly understood.

In this study, investigators will evaluate the effect of dexmedetomidine on preventing postoperative nausea and vomiting in children in comparison with dexamethasone and ondansetron

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients 6-12 years.
* Pediatric patients (ASA physical status I, II).
* Scheduled for dental rehabilitation surgery

Exclusion Criteria:

* Parental refusal
* Allergy or contraindication to studied medication or anaesthetic agents.
* Children with known gastroesophageal reflux disease.
* Intake of antiemetic medication within 24 hours before surgery.
* Past history or family history of previous postoperative nausea and vomiting.
PUFAs and Left Ventricular Function in Heart Failure

The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular systolic function in patients with stable chronic HF secondary to nonischemic dilated cardiomyopathy (NICM).

The results of the GISSI-HF trial indicate that in patients with chronic HF on evidence-based medical therapy and New York Heart Association (NYHA) functional class II-IV, long term treatment with n-3 PUFAs 1 g daily reduces mortality and hospitalizations for cardiovascular reasons. Several potential mechanisms may underlie the beneficial effects of n-3 polyunsaturated fatty acids (PUFAs) in HF patients, including, but not limited to, antiarrhythmic, and hemodynamic actions. The current investigation was therefore designed to test the hypothesis that treatment with n-3 PUFAs improves LV systolic function expressed as EF in patients with stable chronic HF secondary to a nonischemic dilated cardiomyopathy (NICM). Additionally, we sought to determine if n-3 PUFAs also exert positive effects on LV diastolic function assessed by echocardiography; functional capacity assessed by cardiopulmonary stress testing (CPET); and New York Heart Association (NYHA) functional class.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of non ischemic cardiomyopathy (the absence of coronary artery disease,defined as the absence of stenosis \> 50%, was confirmed by angiography performed at the time of the diagnostic workup of the cardiomyopathy)
* LV systolic dysfunction (defined as an EF \< 45%)
* Stable clinical conditions with minimal or no symptoms for at least three month
* Evidence-based medical treatment at maximum tolerated target doses for at least six month

Exclusion Criteria:

* presence of symptoms or evidence of CAD diagnosed through noninvasive tests;
* peripheral arterial disease;
* presence of congenital or primary valvular heart disease;
* persistent atrial fibrillation;
* inability to perform bicycle ergometry for noncardiac causes;
* moderately to severely reduced functional capacity;
* NYHA functional class IV;
* poor acoustic windows limiting the ability to assess echocardiographic measurements;
* chronic lung disease;
* advanced renal disease (eGFR \< 30 mL/min/1.73 m2);
* advanced liver disease;
* any disease limiting life expectancy to one year or less;
* contraindications to study drugs;
* concomitant participation in other research studies
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.


Eligibility Criteria:
Inclusion Criteria:

* Gestational ages between 22 0/7 - 32 6/7 weeks gestation
* \< 25th centile birthweight

Exclusion Criteria:

* Major congenital/chromosomal anomalies
* Terminal illness in which decisions to withhold or limit support have been made
Study of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients

The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis Combination Therapy in Type 2 Diabetes Mellitus Patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as a diabetes mellitus patient at least 3 months ago on screening
* Treated with metformin of ≥ 500 mg/day over 3 months on screening
* Fasting glucose level of 110\~180 mg/dl or HbA1c of 7.0\~9.0% on screening

Exclusion Criteria:

* With acute or chronic inflammation
* Treated with systemic corticosteroids within 4 weeks prior to the first administration of study medication
* With heart failure, myocardial infarction, stroke, or other acute severe cardiovascular diseases
* With acute or chronic renal failure or nephrotic syndrome
* With impaired hepatic function.
* Drug or Alcoholic abuser
* Pregnant or nursing woman
Intelligent Lung Support in the Intensive Care Unit

The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers.

The main question of the study:

How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, age ⪰18 years
2. Written informed consent
3. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.

Exclusion Criteria:

1. Expected to die within ≤48 hours
2. Participation in an interventional mechanical ventilation trial
3. Mechanical Ventilation with a closed-loop ventilation mode
4. Persons dependent on the sponsor and/or investigator
5. Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities
Mechanisms for Organ Dysfunction in Covid-19

The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.

Consenting patients with suspected or verified SARS-COV-2 infection, COVID-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. Data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. The collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care
* suspected or verified COVID-19

Exclusion Criteria:

* Pregnancy or breastfeeding
* Under-age
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers

To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Participants with Fitzpatrick skin type II or III
* Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus \[HIV\], B and C hepatitis analysis at screening)
* Written informed consent and data privacy consent obtained

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study
* Participant participating to another research on human beings or being in an exclusion period for a previous study
* Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study
* Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start
* Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand)
* Participant having received injections of permanent or semi-permanent filling products in the studied zones
* Participant under anti-coagulant treatment or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study
* Participant receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (herbal supplements with garlic or ginkgo biloba, etc) for 10 days prior to study treatment and 3 days after
* Participant under immunosuppressive therapy
Review of Breast Abscess Management

Breast abscesses are an unfortunate pathology that develop in patients, and treatment is often painful and unpleasant. The goal of this study is to identify risk factors associated with failure of aspiration as a primary intervention as opposed to incision and drainage in the hopes of adequately treating patients at initial presentation.

The pendulum has now swung toward minimally invasive aspiration as the primary treatment modality, with multiple studies reporting superior cosmetic results. However, patients in these studies often required repeat breast aspirations, and sometimes ultimately required incision and drainage. Aspiration first for treatment of breast abscess may not be a wise choice for all patients if it results in increased antibiotic days, return to emergency department (ED)/increased cost, or prolonged pain from multiple procedures. Several studies have identified varying risk factors for aspiration failure as primary intervention for breast abscesses. More data is needed to confirm the true risk factors for failure.

Eligibility Criteria:
Inclusion Criteria:

* • ≥18 years of age

  * New diagnosis of N61.1 recorded in their Electronic Medical Record (EMR)

Exclusion Criteria:

* • \<18 years of age

  * Pregnant
  * Incarcerated
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of diabetes mellitus type 1 or type 2 with

  * Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
  * Presence of bilateral pain in lower extremities due to DPN for at least 1 year

Key Exclusion Criteria:

* Painful neuropathy other than DPN
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months

Other protocol defined Inclusion/Exclusion criteria may apply.
Long-Term Follow-Up of Subjects Treated With AXO-AAV-GM2 for Tay-Sachs or Sandhoff Disease

This study is to continue Long-Term Follow-Up of Patients who were previously treated with AXO-AAV-GM2 Gene Therapy as treatment for Tay-Sachs or Sandhoff Disease to follow the subjects through 5 years after their initial gene therapy treatment.

Subjects will be contacted bi-annually for a total of five years following the administration of AXO-AAV-GM2 for the collection of clinical information, especially pertaining to de novo cancer, neurologic, rheumatologic, and hematologic/immunologic disorders. This will be done to comply with FDA Recommendations and NIH Guidelines for long-term follow-up for research involving gene therapy with AAV Vectors.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were previously enrolled in the study "A Two-Stage Dose-Escalation Study to Evaluate the Safety and Efficacy of Bilateral Intraparenchymal thalamic and intracisternal/Intrathecal Admin of AXO-AAV-GM2 in Tay-Sachs or Sandhoff Disease."

Exclusion Criteria:

* Subjects who were not previously enrolled under the initial protocol.