cyrilzakka/clinical-trials huggingface dataset:
A Technology-based Intervention to Support Older Adults in Living Independently

The general objective of this study is to test the usability and efficiency of the SAVE prototype, a technology-based support for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible.

The SAVE system aims to offer technology-based support to older adults for staying in their familiar surroundings for as long as possible, while feeling safe and optimally cared for. The SAVE technology has been designed and developed according to the approach of the User Centered Design (UCD), which involves multiple interactions with users to under-stand their needs and preferences and to involve them in the design process for creating a truly useful and appreciated technological product. Secondarily, it supports informal caregivers, like relatives, in providing optimal care for their loved ones, while maintaining their professional and private life. The general objective of this study is to test the usability and efficiency of the SAVE prototype for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible. The study involves the use of the SAVE platform for a total of 21 consecutive days.The study involves the use of a mixed-methods approach, in which both qualitative (open questions) and quantitative (standardized tests) data will be collected, and three different measurements (T0, T1, T2) will be made during the period of use of the system. The data collection card will therefore be divided into two different sections, which correspond to the three different moments of detection: 1) at time 0, that is, before the start of the experi-mentation (T0); 2) at time 1, after 10 days, i.e. at the midterm of the trial (T1), and 3) at time 2, after 21 days, i.e., at the end of the trial (T2). The log data of the usage of the SAVE sys-tem be the primary, secondary, and tertiary users will be continuously stored over the 21 days test period.

Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Evaluation (MMSE) between 21 and 24
* Healthy or mild to moderate chronic illness or musculoskeletal disease
* Feel physically fit to participate in the study

Exclusion Criteria:

* Participants suffer from severe chronic disease
Safety and Efficacy Study of Spinal Tethering

This study is an opportunity to gather long term safety and efficacy information from patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).

Participants in this study will have already been implanted with a vertebral body tethering device. Patients will be recruited for prospective follow-up to enable systematic data capture from the point of study entry to their 18th birth year and skeletal maturity. Over the course of their follow-up clinical outcomes, patient reported outcomes, and radiographic outcomes will be tracked.

Eligibility Criteria:
Inclusion Criteria:

* Patients who assent/consent to participate in this study for prospective surveillance
* Patients at least 10 years old, inclusive, on the day of surgery
* Patients with idiopathic scoliosis
* Patient who has failed bracing (as defined by greater than 5° of progression and/or intolerance to brace wear)
* Patients who underwent an anterior vertebral body tethering procedure for treatment of scoliosis via thoracoscopic access or mini-thoracotomy
* Patients with a Lenke type 1 curve with lumbar modifier of A or B
* Patients whose pre-operative Cobb angle was ≥ 30° and ≤ 65°
* Patients whose pre-operative thoracic scoliometer reading is ≤ 20°
* Patients whose structural, thoracic curve bends out to ≤ 30° Cobb angle pre-operatively

  * Ideally supine bending film
  * Standing lateral bending film also acceptable
* Patients of Sanders stage ≤ 5 or Risser sign of ≤ 3 at the time of surgery
* Patients and parents that understand English

Exclusion Criteria:

* Patients with vertebral body staples at any level of their spine

  ---Specifically, vertebral body staples that span an intervertebral disc space and are implanted for fusionless correction of scoliosis
* Patients with any spine surgery prior to their VBT procedure
* Patients with any deformity correction surgery, on their Lenke 1 curve, after their VBT procedure
* With the exception of tether re-tensioning
* Patients with any vertebral bodies that were instrumented outside of a thoracoscopic or minithoracotomy approach in conjunction with their VBT procedure
* Patients that have an orthotic prescribed and used to correct their Lenke 1 curve any time after their VBT procedure but before the 2 year primary endpoint
* Patients who are pregnant
* Patients unwilling to return for prospective follow-up visit(s)
* Patients with major psychiatric disorders (as defined in DSM-5)
* Patients with a history of substance abuse (as defined in DSM-5)
* Patients who are wards of the court
* Patients who are in an active drug or device trial that is more than minimal risk and where their participation in the trial would confound the measurements of the present study
* Patients who are in a device trial for efficacy of a musculoskeletal device and where their participation in the trial would confound the measurements of the present study
* Patients who are less than 30 days out from completion from another clinical trial of more than minimal risk or for safety and efficacy
* Patients for whom the investigator deems unwilling/incapable of participating
Hybrid Intubation Technique for Difficult Airway Children

To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult intubation.


Eligibility Criteria:
Inclusion Criteria:

* Children from 1 month of age to less than 12 years of age who are expected to have a difficult intubation when undergoing routine surgery under general anesthesia.

Exclusion Criteria:

* When there is limited mouth opening, making it difficult to insert supraglottic airway ② The patient or their parents do not agree to participate in the study. ③ Other cases deemed unsuitable by the researcher
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.

1. To assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with Alpelisib for metastatic breast cancer.
2. To assess the feasibility and safety of treatment with pioglitazone in these patients.
3. To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.
4. To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.
5. To assess the median progression free survival of patients treated according to this protocol

Eligibility Criteria:
Inclusion Criteria:

* Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.
* Ages 18 - 85
* ECOG performance status 0, 1 or 2
* Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib
* Uncontrolled diabetes mellitus, defined as HbA1c above 8%
* Diabetes mellitus controlled by insulin
* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnancy
* Known allergy to pioglitazone
Cognitive Enhancement Through Transcranial Laser Therapy

This is a mechanism-driven translational project to test the efficacy of transcranial low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and older adults and participants with Mild Cognitive Impairment.

The goal of this project is to test the efficacy of LLLT to enhance neurocognitive function in middle-aged adults and examine the modulating influences of carotid atherosclerosis. The specific aims will be accomplished in a randomized controlled trial (RCT) by examining cognitive test performance and blood oxygen level-dependent (BOLD) response to a working memory task in middle-aged and older adults and participants with Mild Cognitive Impairment pre- and post- six-week long intervention of LLLT or placebo. In addition, the investigators will examine if carotid artery intima-media thickness (IMT) moderates the therapeutic effects of LLLT.

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women, aged 45 and older
* Participants with Mild Cognitive Impairment

Exclusion Criteria:

* neurological disease (e.g., large vessel stroke, seizure disorder, Parkinson's disease, Alzheimer's disease, clinically significant traumatic brain injury with loss of consciousness \> 30 minutes, multiple sclerosis, or brain infection/meningitis
* baseline IQ \< 85 placing them below the average range of intellectual functioning
* major psychiatric illness (e.g., schizophrenia, bipolar disorder) or substance abuse (diagnosed abuse and/or previous hospitalization for substance abuse)
* severe cardiovascular disease (e.g., pacemaker), chronic obstructive pulmonary disease, liver or kidney disease, inflammatory illness
Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia.

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* endo colostomy
* Informed consent

Exclusion Criteria:

* age \< 18 years;
* life expectancy \< 24 months (as estimated by the operating surgeon)
* pregnancy
* immunosuppressant therapy within 2 weeks before surgery
The Alberta Primary Care Endoscopy (APC-Endo) Study

It is hypothesized that primary care colonoscopists are able to achieve benchmarks in colonoscopy quality including cecal intubation and adenoma detection rates and serious adverse event rates.

This prospective study is the first in depth analysis of the quality of colonoscopic procedures performed by primary care physicians at a provincial level in Canada.

In addition, the APC Endo study is the first to directly examine both the quality of colonoscopy and patient satisfaction in the same study.

Discrepant data exists about the quality of colonoscopies performed by family physicians and general internists. Currently in Canada, gastroenterologists and general surgeons perform 97% of the colonoscopies, but excessive wait times highlight a shortage of colonoscopists in Canada. This shortage will invariably worsen as our population ages and more Canadians become screened for colorectal cancer.

One method of improving this relative shortage of colonoscopists is through training primary care physicians in GI medicine and endoscopy. In order these physicians to be a legitimate option in the provision of colonoscopies; however, it must be shown that, as a group, they are able to meet benchmarks in colonoscopy competency.

This multi-centre observational study will be the first study to prospectively analyze colonoscopic examinations performed by primary care physicians at a provincial level. Using primarily cecal intubation rates and adenoma detection rates, along with other quality parameters, this study will compare the results of Alberta primary care physicians to standard benchmarks in colonoscopy competency.

Data will be collected using case report forms completed at the time of the colonoscopy, reviewing the patients' colonoscopy pathology results and a post procedure telephone survey to examine patient satisfaction rates.

If this study demonstrates that quality benchmarks are indeed met, then future training of primary care physicians in gastrointestinal medicine and endoscopy would be encouraged to help address current and future colonoscopist shortages.

Eligibility Criteria:
Inclusion Criteria:

* All patients having a colonoscopy done by an APC-Endo physician endoscopist during the study period will be approached at the time of their endoscopy to consent to the post procedure telephone.

Exclusion Criteria:

* Patients under the age of 18 years old
* Patients who will be unable to be contacted for the post procedure telephone survey. (e.g., moving out of the country in the following month)
* Patients who are unable to understand or speak basic English
* Patients who are cognitively impaired such that they were not able to complete the initial consent for their colonoscopy
Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis

Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery.

The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.


Eligibility Criteria:
Inclusion Criteria:

* Any patient for which the diagnosis of GCA is suspected and who underwent a cervical PET/CT

Exclusion Criteria:

* previously diagnosed GCA, glycemia \> 7 mmol/L, PET CT performed more than 72 h after introduction of glucocorticoids, age \< 50 years
Genetics of Neural Tube Defects

The Genetics of Neural Tube Defects Study at the University of Miami: The University of Miami John P. Hussman Institute for Human Genomics is looking for families to participate in research to identify the genetic and environmental factors that contribute to Neural Tube Defects (NTD). Our research goal is to better understand the genetic and environmental causes of both open NTD, like spina bifida and anencephaly, and closed NTD, like lipomeningocele and tethered cord. This will eventually lead to more accurate genetic counseling and risk assessment, improved treatments, and better prevention methods. Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing. Participation is free. Travel is not required. Participation involves reading and signing a consent form, providing a blood sample, a family and medical history interview, and granting the research staff permission to review the medical records of the individual(s) with NTD. We maintain the highest standards of confidentiality for all families. If interested, please contact Maria Ciliberti, the study coordinator, at 1-877-686-6444 (toll free) or directly at 305-243-4360, or by email Mciliberti@med.miami.edu . Please visit our web site at www.hihg.org for more information.


Eligibility Criteria:
Inclusion Criteria: Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing -

Exclusion Criteria: Pregnant children will not be enrolled

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A Dose-escalation Study of AND017 in Healthy Subjects

This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral single and multiple dose administration.


Eligibility Criteria:
Inclusion Criteria:

1. BMI within 18.0-30.0 kg/m2 (inclusive)
2. Blood Pressure (BP) and 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities during screening;
3. No clinically significant abnormal values in physical examination, clinical laboratory tests, liver function or kidney function;

Exclusion Criteria:

1. Current or chronic history of liver disease or known hepatic or biliary abnormalities, including but not limited to ALT, alkaline phosphatase and bilirubin \>1.5xULN (isolated bilirubin\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%);
2. Subjects with Hb: male \<120 g/L or \>160 g/L, female \<110 g/L or \>150 g/L;
3. Subjects with any abnormalities of hematology during screening: Mean corpuscular volume (MCV), platelet count, serum iron, ferritin;
4. Subjects with a history of medical treatment or disease likely to increase the risk of bleeding or disturbance of blood coagulation;
5. History of deep vein thrombosis, stoke, transient ischemic attack, pulmonary embolism or other thrombosis-related condition within the last five years;
6. History of myocardial infarction, heart failure or acute coronary syndrome;
7. Evidence of active peptic, duodenal or esophageal ulcer disease at screening;
8. History of pulmonary artery hypertension;
9. History of sensitivity to heparin or heparin-induced thrombocytopenia;
10. Subjects with major illness or surgery within past 3 months prior to screening, or planned surgery during study;
11. Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before study;
12. Donated blood \>400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3months of screening; or donated blood \>200 mL or significant blood loss equivalent to 200 mL within 1 month prior to screening.
13. Participation in any clinical study with an investigational drug, biologic or device within 4 weeks or 5 times the half-life of the specific drug/biologics (whichever is longer), prior to dosing;
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers

The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.

Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 21-45
* Current marijuana use
* Able to perform study procedures
* Women practicing an effective form of birth control

Exclusion Criteria:

* Female subjects who are currently pregnant or breastfeeding
* Current,repeated illicit drug use other than marijuana
* Presence of significant medical illness
* History of heart disease
* Request for drug treatment
* Current parole or probation
* Recent history of significant violent behavior
An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity.
* Aged 18 to 85 years old, inclusive.
* Patient or legal representative is able, willing, and competent to give informed consent.

Exclusion Criteria:

• Employees of the sponsor or patients who are employees or relatives of the investigator.
Institut Paoli Calmettes Breast Cancer Database

Database of Institut Paoli-Calmettes patients diagnosed with breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of breast cancer

Exclusion Criteria:

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