cyrilzakka/clinical-trials huggingface dataset:
Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes

A sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes.

Type 2 diabetes (T2D) is a major risk factor for adult morbidity and mortality and represents a public health burden due to its rising global prevalence. T2D is preceded by prediabetes, a phase characterized by higher-than-normal blood glucose levels that do not reach the threshold required for a T2D diagnosis. It is estimated that 70% of people with prediabetes will eventually develop T2D, with a mean annual incidence rate ranging from 5% to 10%.

Importantly, socioeconomic status exacerbates the risk of developing chronic diseases such as T2D, as people from underprivileged social classes are significantly more susceptible to the development of the disease and its complications, when compared to the more privileged.

In fact, it has been observed that the risk of developing T2D extends beyond physiological factors. Social determinants (SD) such as age, gender, ethnicity, postal code, or socioeconomic status, and health beliefs are strong predictors of disease onset and progression. Populations with a low socioeconomic status (i.e., economically disadvantaged backgrounds, lower health literacy levels, lower educational status, and often, from ethnic and racial minorities), are known to experience reduced access to healthcare including health promotion programs. They also have lower adoption rates of health behaviors, such as physical activity (PA) and healthy diet, and thus be at increased risk of chronic diseases such as T2D, which finally increases their likelihood to suffer inequalities in mortality.

For all of the above, this study aims to explore the influence of SD on adherence behaviors in individuals with prediabetes included in the PREDIPHONE trial, using a mixed-methods sequential explanatory design. The findings from both the quantitative and qualitative phases will be integrated to offer a comprehensive understanding of the complex phenomenon of adherence.

Eligibility Criteria:
Inclusion Criteria:

* participants of the PREDIPHONE trial assigned to the intervention group and who complete the 9-month intervention period

Exclusion Criteria:

* Participants from the control group or those who withdrew from the trial.
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet

To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.
Observational Study of Keloids Scars Treated by Shaving and Cryosurgery

Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery


Eligibility Criteria:
Inclusion Criteria:

* keloids scars
* treatment of shaving and cryosurgery

Exclusion Criteria:

* immunosuppressive therapy
* chemotherapy
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.

Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III \& IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between the ages of 18 and 70
* Any patient with a stage III/IV pressure ulcer of the size large enough to indicate use of Negative Pressure Treatment.

Exclusion Criteria:

* Clinical evidence of active, gross infection.
* Patient or patient's guardian refuses consent.
NLP to Aid in the Evaluation and Diagnosis of FGIDs

The study has two arms, where the same natural language processing (NLP) and probabilistic graphical modeling technology will be utilized on patients' report of symptoms in both arms. The clinical arm is focused on patients presenting for consultation with a gastroenterologist. The endoscopy arm is focused generally on patients presenting for a diagnostic endoscopy, with the goal of capturing Functional Gastrointestinal Disorder (FGID) patients prior to diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for consult in the Motility Clinic in the MGH Gastroenterology Unit or for diagnostic endoscopy in the MGH Gastroenterology Unit
* Patient must agree to have their interactions audio-recorded
* Informed consent form signed by the subjects

Exclusion Criteria:

* Non-native English speaker
* Patients unable to communicate their own symptoms
Evaluation of a Novel Patient Warming System During MRI

Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Cardiac MRI scans performed for patients who require general anesthesia can cause a loss of body heat.

Several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no MRI-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the MRI-scanner.

This study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI scanner.

A. Each group will receive the usual clinical care for having an MRI under general anesthesia:

1. General anesthesia. The type of anesthesia used will be determined by the individual anesthesiologist, and will be the safest technique possible to allow for the desired MRI images to be obtained.
2. All participants will be covered with 1-2 warm blankets before receiving anesthesia and while in the scanner as part of standard warming measures.
3. All participants will have continuous temperature monitoring during the scan.

B. Participants will be randomized to one of the three

1. 20 subjects will receive the standard of care which is 1-2 warm blankets. This group is called the control group.
2. 20 study subjects will have the MRI-safe bore covering applied. This includes a clear covering sheet positioned over the openings of the MRI scanner.
3. 20 study subjects will have the MRI-safe bore covering applied, and in addition one opening of the covering sheet will be connected to a "Bair hugger" ( an approved device which blows warm air). The second opening will act as a vent to let air out of the MRI scanner bore. The Bair hugger will be programmed to deliver forced air at 38 degrees Celsius (approximately 100 degrees Fahrenheit) into the contained space within the MRI scanner.

Body temperature will be monitored continuously and documented in the electronic anesthesia record. The temperature of the forced air will be adjusted to maintain a goal body temperature of 36-38 degrees Celsius (96.8- 100.4 degrees Fahrenheit).

Image quality will be evaluated by the MRI-technologist and MRI -cardiologist subjectively.

Eligibility Criteria:
Inclusion Criteria:

1. Children \< 7 years of age.
2. Undergoing medically necessary cardiovascular MRI under general anesthesia

Exclusion Criteria:

1.Patients with fever (temperature \>38.5 degrees Celsius) or condition which require active cooling at the time of MRI
TDM of Asparaginase in ALL2008

Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.

Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018.

From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future.

A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.


Eligibility Criteria:
Inclusion Criteria:

* ALL treated on the NOPHO ALL2008 protocol, age 1-45 years.

Exclusion Criteria:

* No samples sent
Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects With Lewy Body Dementia

This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.

This is a double-blind, randomized, placebo-controlled, cross-over study in subjects with Lewy body dementia who experience frequent visual hallucinations.

Subjects who meet the randomization criteria enter the double-blind treatment period.

Each subject will be randomized 1:1 to one of the 2 treatment sequences: Nelotanserin in the first treatment period followed by placebo in the second treatment period, or placebo in the first treatment period followed by Nelotanserin in the second treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects at least 50 years of age, with a diagnosis of LBD based on DSM-5 diagnostic criteria or diagnosis of Parkinson's disease dementia (PDD) based on DSM-5 diagnostic criteria;
* Presence of frequent visual hallucinations
* Mini Mental State Examination score ≥ 18

Exclusion Criteria:

* Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
* Subjects' psychotic symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
* Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults

The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
* Diagnosis must be obtained by a stereotactic or surgical biopsy
* Age between 18 and 70
* Total or partial surgical resection deemed as not possible by a neurosurgeon
* OMS performance status 0 or 1
* Adequate blood function : absolute neutrophil count \> 1.5 x 109/L, platelets count \> 100 x 109/L platelets;
* Adequate liver function: bilirubin \< 1.5 ULN (upper limit of normal), ALT and AST \< 3 ULN,
* Adequate renal function: creatinine \< 1.5 ULN
* Patient must have been informed and must have signed the specific informed consent form.

Exclusion Criteria:

* other malignancy histology
* resection of the brain tumor complete on MRI exploration
* patient unable to give informed consent
* patient presenting counter-indication to MRI exploration
* patient must not have received neither radiotherapy nor chemotherapy for that affection
* concomitant malignancy
* patient already enrolled in another biomedical study with an experimental molecule
* pregnant, nursing woman, or without contraception
* private individuals of freedom or under tutelage (including legal guardianship)
* psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)
A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.


Eligibility Criteria:
Inclusion Criteria:

* All ages
* Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools
* Healthy volunteer subjects
* Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian

Exclusion Criteria:

* Allergy or intolerance to ultrasound gel or mineral oil used for imaging
* Patients who are not able to comply with imaging procedure
CHARITE™ vs. ALIF 5-Year Follow-up

To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).

This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.

This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.

Eligibility Criteria:
Inclusion Criteria:

* Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
* Still have the original implant they received in their index surgery.

Exclusion Criteria:

* None
Wearable Devices System Diagnoses Mood Disorder in Children and Adolescents

As a diagnostic test, this study aims to explore the effectiveness of systems based on wearable devices in identifying mood disorders in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Subjects in the MDD group met the DSM-5 diagnostic criteria for MDD and those in the BD group met the DSM-5 criteria for BD
* able to cooperate to complete the study
* had signed the informed consent prior to the study

Exclusion Criteria:

* with severe physical illness
* demonstrated symptoms comorbid with other psychiatric disorders (e.g., schizophrenia, conduct disorder, personality disorder) and developmental disorders (e.g., autism spectrum disorder, intellectual impairment)
* other conditions deemed inappropriate for inclusion in the group
Gender Bias and Overtreatment in Primary Care

The purpose of this study is to analyze if there are differences between men and women in the frequency of ignoring "Do not do" recommendations in primary care setting.

First, using the Delphi technique, a consensus will be reached on those "Do Not Do" recommendations that should be included in the retrospective analysis study. The selection criteria for these recommendations will be if they are about pharmacological treatments, considered to persist in clinical practice in primary care, their relationship with factors associated with sex and gender, and if ignoring the "Do not do" recommendation could cause a serious adverse event.

Second, a retrospective cohort study will be carried out including patients who attended primary care consultation in Alicante from 1st January 2022 to 31st December 2022. Data source will be the electronic record management system of the autonomous community of Valencia (named ABUCASIS), and they will be provided by the Ambulatory Assistance Information System (SIA-GAIA). Investigators will analyze the frequency of ignoring the "Do not do" recommendations previously selected by consensus by sex and age range.

Eligibility Criteria:
Inclusion Criteria:

* Attending primary care consultation from 1 January 2022 to 31 December 2022.
* Adults

Exclusion Criteria:

* None
Asan Aorta and Peripheral Registry

The purpose of this study is to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at Asan Medical Center.

This study is a single center retrospective and prospective observational study to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at asan medical center.

Data will be collected on approximately 6,000 subjects in asan medical center. Individuals will be followed up at 1, 6, and 12 months, 3, 5years up to 10 years by telephone call or hospital visit.

Data collected during all follow-up visits will include a composite of major adverse limb events, or death from any cause.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the Peripheral Vascular Disease Center, Asan Medical Center
* Patients with aortic and peripheral artery disease are defined as:

Thoacic aorta disease/ abdominal aorta disease

1. Aneurysm
2. Aortic dissection
3. Penetrating aortic ulcer

Peripheral artery occlusive disease

1. Chronic Limb-Threatening Ischemia
2. Claudication
3. Acute limb ischemia

Exclusion Criteria:

* For prospective cohort, not agreeing to participate with written informed consent form
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects

The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;
* At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus \[T2DM\] or prediabetes, or obstructive sleep apnea).
* Must be ambulatory, willing, and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.

Exclusion Criteria:

* Screening blood pressure of \> 140/90 mmHg;
* Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;
* Clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease;
* History of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act;
* History of glaucoma;
* Night shift workers;
* Obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and
* Smoking cessation within 3 months prior to screening;
* Use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or CPAP therapy that has not been stable for at least 3 months prior to randomization;
* COVID-19 vaccination or treatment for severe COVID-19 infection within a month prior to randomization.
Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes

This study evaluates the addition of using a sock of silicone to using a heel cream, in the treatment of heel fissures in people with diabetes, aiming at healing the fissures and preventing them from developing into ulcers. Half of the participants will use the silicone sock and a heel cream, the other half will use the cream only.

Dry skin and heel fissures are common complications of diabetes and can develop into hard-to-heal ulcers that eventually can make amputation of the foot necessary.

Patients are advised to use heel creams to heal fissures and prevent them from developing into ulcers. Clinical observations have suggested that wearing a silicone sock nighttime can heal fissures, but the additional advantage of using a silicone sock compared to use a heel cream only has not been investigated.

Participants will be randomized to an intervention group (silicone sock and heel cream) or a control group (heel cream only) and the healing of fissures and development of new ulcers will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes diagnosis, and
2. Deep heel fissures

Exclusion Criteria:

Factors associated with increased risk of complications:

1. known allergy or hypersensitivity to silicone or ingredients in cream
2. other skin conditions that make use of sock or cream inappropriate
3. strongly fluctuating foot edema
4. ulcer in part of the foot that the sock is in contact with
5. inability of participant or assisting person to handle the silicone sock correctly including daily cleaning.

Factors associated with increased risk that complications are not discovered or reported, such as, dementia, language or other communication impairments, intellectual disability or known substance abuse, AND there is no other person who can provide adequate support to the participant.
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB.


Eligibility Criteria:
Inclusion Criteria:

* Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB).

Exclusion Criteria:

* Requires an emergent or "emergency" CABG and/or cardiac valve replacement.