cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits

INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Medical advice is useful for determining changes in the habits of life of patients, however, the changes produced by the council do not last over time, so it would be necessary to establish enforcement mechanisms as with mobile technology, because it could improve the adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open randomized controlled clinical trial with clinical practice (health advice for physical activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm). Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance analysis adjusting by baseline weight, and other confounding variables (sex, age, level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.


Eligibility Criteria:
Inclusion Criteria:

* BMI\> = 25 mg / kg
* Holder smartphone
* Sign informed consent

Exclusion Criteria:

* Presence of physical or mental illnesses that prevent the realization of physical activity
* Be participating in another research project
* Pregnancy or lactation
* Patients who are on diet or drug treatment for weight loss
* History of myocardial infarction or stroke
Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.


Eligibility Criteria:
Inclusion Criteria:-

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
* Male or female, age 18 years or older at the time of signing informed consent.
* Type 2 diabetes mellitus diagnosis.
* Treatment with either 1 or 2 oral antidiabetic medications.
* Current member of a commercial or Medicare health plan with pharmacy benefits.
* Recorded HbAlc value within the last 90 days prior to randomization.
* Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling.

Exclusion Criteria:

* Previous randomization in this study
* Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes.
* Contraindications to semaglutide according to the Food and Drug Administration approved label.
* Female who is pregnant, breastfeeding or intends to become pregnant
* Participation in another clinical trial.
Postmarket Registry for Evaluation of the Superion® Spacer

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients ≥45 years of age
* symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
* meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)

Exclusion Criteria:

* not contraindicated as described in the labeled indications for use
Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-deried stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Investigators plan to include 10 patients with unilateral lymphedema after previous breast cancer treatment

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
3. The opposite upper extremity is healthy.
4. ASA score of 1 or 2.
5. The patient is able to read, understand, and complete Danish questionnaires.
6. Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.

Exclusion Criteria:

1. The patient is pregnant or lactating.
2. The patient has bilateral lymphedema of the upper extremities.
3. The patient has or has had other malignancies other than breast cancer.
4. The patient is treated with anti-diabetic medication.
5. The patient is diagnosed with any form of psychotic disorder.
6. The patient is smoking.
Dexmedetomidine on Prevention of Side Effects of Hemabate

Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.


Eligibility Criteria:
Inclusion Criteria:

gynecological patients

Exclusion Criteria:

* Neuromuscular and endocrine diseases
* Allergic reactions to a2-adrenergic agonist
* Previous abdominal surgery including prior caesarean section.
Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease

The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .

Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.

This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.

The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .

Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.

This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. Received a liver transplantation between 2018 and 2022 (3) Liver transplantation was performed by SLT or WLT

Exclusion Criteria:

1. Re-LT
2. Multiorgan transplantation
3. Survival≤one week after LT
4. Incomplete data
Natural History of Oro-pharyngeal Cancer Precursors

Oro-pharyngeal cancers can develop from squamous dysplastic precursor lesions, which occur in a subset of common white (leukoplakia), red (erythroplasia), or mixed oro-pharyngeal plaques. Known risk factors for oro-pharyngeal cancer include tobacco smoke, alcohol consumption, diet and, in a subset of tumors, human papillomavirus (HPV). Along the oro-pharyngeal disease continuum, there may be variations in gene expression precursor lesions as a result of exposure to smoking, alcohol and HPV. However, the components of gene expression that are most likely associated with tumorigenesis in these tissues are poorly understood. This study will focus upon early gene expression profiles in the oral cavity and oropharynx in subjects who have precursor lesions and have been exposed to the common risk factors for carcinoma development including smoking and HPV infection. This application is to conduct pilot testing and establish appropriate procedures for an international prospective cohort study of the natural history of oro-pharyngeal cancer precursors among men and women at high risk of oro-pharyngeal cancer at Montefiore Medical Center, Bronx-NY. Brush biopsy specimens will be used to collect a transepithelial sample of cells from oro-pharyngeal plaques, as well as normal tissue from defined regions of the oral and pharyngeal mucosa. Measurement of gene expression will employ novel high-throughput cDNA microarray analysis and PCR-based HPV DNA testing. Oro-pharyngeal dysplasia will be diagnosed using cytopathology. Under this application, we will assess our planned instruments and procedures on an initial sample of 40 subjects. This planning period will allow for precise identification of methodologies, standardization of instruments and assays to be utilized by additional participating centers in a subsequent application.


Eligibility Criteria:
Inclusion Criteria:

* Established residence in the greater Metropolitan area of New York City, including Westchester, Long Island, Southern Connecticut and Northern New Jersey

Exclusion Criteria:

* No history of therapy for oral cancer in the previous 6 months
Wallis Stabilization System for Low Back Pain

The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.

This study will assess the safety and efficacy of the Wallis® System compared to commercially available lumbar TDR with respect to individual subject success rates at 24 months postoperative follow-up.

Study participants will receive all study related test articles and surgical procedures at no charge. Please scroll down to the "Locations" section to find a doctor in your area that is participating in this study. If you are interested in participating in this study and do not see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 (inclusive) and skeletally mature.
* Diagnosis of mild to moderate DDD at L4-L5 as confirmed by radiography.
* Minimum of six months of failed conservative treatment.
* Pre-operative visual analog (VAS) low back pain score ≥ 40, on a scale of 100mm, with low back pain greater than left or right leg pain.
* Preoperative baseline Oswestry Disability Index (ODI) score of ≥ 40 on a 100 point scale.
* Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
* Voluntarily signs the patient informed consent form.
* Patient is a surgical candidate for an anterior approach to the lumbar spine (\< 3 abdominal surgeries).

Exclusion Criteria:

* The investigator believes that the L1-L2, L2-L3, L3-L4, or L5-S1 level is symptomatic based upon objective evidence, e.g., radiograph, MRI, or discography.
* Evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the L4-L5 or adjacent levels.
* Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan (T score \< -1.0). Female subjects older than 45 years of age (or post-menopausal women, history of oophorectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (DEXA) of the lumbar spine. The DEXA will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. Subjects with a T-score of less than -1.0 will be excluded from the study.
* Congenital lumbar spinal stenosis.
* Bony lumbar stenosis.
* Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI \> 40kg/m2).
* A history of any surgical procedure intended to remove or alter the disc (e.g. discectomy, intradiscal electrothermal therapy (IDET) or enzymes), decompress (laminectomy) or fuse, either the index or adjacent levels.
* Prior participation in study of any investigational spinal implant or investigational spinal treatment.
Goal Directed Hemodynamic Management and Renal Outcome After Major Non-cardiac Surgery

This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.

Acute kidney injury (AKI) is a common complication after major surgery. Many studies showed that AKI is associated with different complications: higher mortality, renal replacement therapy and prolonged hospital stay resulting in higher health care costs.

Until now just a few studies are published on prevention or therapy of AKI after major surgery. Most of these investigations are underpowered or show just marginal benefit. There are no studies published investigating the impact of goal-directed hemodynamic management on renal outcome following non-cardiac major surgery, even though hemodynamic stability seems to be of paramount importance for the kidneys.

Aim of this study is to investigate the impact of a goal directed hemodynamic management on renal outcome after major non-cardiac surgery.

Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management and the Control group, where PICCO data will be collected but will not influence hemodynamic management. In both groups the monitoring with transpulmonary thermodilution will be continued in the intensive care unit until 72 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:

  * gastrectomy
  * pancreas surgery
  * small bowel surgery
  * esophageal surgery
* Age ≥ 18 years
* ASA classification I to III
* Written informed consent

Exclusion Criteria:

* Need for dialysis
* Contraindications for an arterial line in the femoral artery:

  * stents
  * bypasses
  * severe peripheral artery occlusive disease
* ASA classification IV to V
* Pregnant Woman
Assessment of Digital Consultations on Clinical Impact and Efficiency

Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. It is and will in the future be challenging to deliver optimal HF care because of personnel shortages, the high costs of healthcare, intensive GDMT uptitration schedules, and an epidemic rise in HF patients.This study aims to evaluate the impact of digital consultations (DC) on efficiency and clinical impact in heart failure (HF) patients.

A randomized controlled trial on multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. Included patients will be randomly (1:1) assigned to the intervention group or standard care.

The ADMINISTER trial is expected to offer the first robust randomized controlled multicenter data of GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, patient satisfaction and quality of life of digital consults in GDMT optimization.

Introduction: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consultations (DC) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. Hence, the investigator initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled trial to evaluate efficacy and safety of DC in patients on HF treatment.

Methods: Patients (n = 150) diagnosed with HF with a reduced ejection fraction (HFrEF) will be randomized to DC or standard care (1:1). The intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. The consultations are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, secondary outcomes include time till full GDMT optimization, patient and clinician satisfaction, time spent on healthcare, and Kansas City Cardiomyopathy questionnaire. Results will be reported in accordance to the CONSORT statement.

Conclusion: The ADMINISTER trial will offer the first randomized controlled data on GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient and clinician targeted DC for GDMT optimization.

Eligibility Criteria:
Inclusion Criteria:

* HFrEF

Exclusion Criteria:

* Patients not in possession of any attributes to perform the consults digitally
The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU

The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation \>24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Admission to the ICU
* Length of mechanical ventilation \> 24 hours
* Stable ventilatory and hemodynamic status defined by positive end- expiratory pressure ≤ 8 cm H2O, inspiratory oxygen fraction ≤ 40%, ratio of arterial oxygen partial pressure to fractional inspired oxygen ≥ 150, respiratory rate ≤ 35 breaths per minute, heart rate ≤ 130 beats per minute and systolic blood pressure between 90 and 160 mmHg.

Exclusion Criteria:

* Patients with primary neuromuscular disease.
* Patients in exclusive paliative care.
* Patients with contraindications to the use of mechanical insufflation- Exsufflation device.